Matthew Perrone

The FDA has proposed requiring food manufacturers to notify the agency and provide written safety justifications before introducing new ingredients or additives through the generally recognized as safe (GRAS) pathway. The measure would give regulators and the public greater visibility into thousands of substances, but it would not require full FDA pre-market approval, and experts warn that most self-certified ingredients would still escape formal review. The agency also says it has finalized a federal definition of ultra-processed foods, though the wording remains under White House review. Robert F. Kennedy Jr. is pursuing the changes as part of the Trump administration’s food-policy agenda and plans to seek expanded congressional authority, while public-health advocates argue that stronger independent safety assessments are necessary.

U.S. health officials expanded the cyclospora outbreak investigation to Illinois, Kansas, Oklahoma and Pennsylvania, bringing the number of affected states to nine for cases linked to lettuce served at Taco Bell. The linked case count reached 1,947, including 98 hospitalizations, while the broader outbreak involved more than 4,100 confirmed and 7,400 probable cases across 41 states. Investigators remained focused on iceberg lettuce supplied by Taylor Farms and grown in Mexico, although Mexican authorities said they found no parasite in samples of lettuce or water from the company’s Guanajuato plant. Officials warned that additional brands, restaurants, retailers or distribution channels could be implicated.

The FDA is reviewing seven peptides popular among wellness influencers and supported by Health Secretary Robert F. Kennedy Jr. Supporters argue that regulated compounding-pharmacy access could help patients avoid the gray market, while FDA scientists and medical experts warn that evidence of safety and effectiveness is sparse, often limited to animal studies, and that contamination, allergic reactions and quality-control problems remain concerns. Several outside advisers have financial ties to the peptide industry, prompting conflict-of-interest criticism. The advisory votes are nonbinding, and the FDA may initially adopt a temporary policy rather than formally add the substances to its compounding-safe list.

Federal health officials continue to investigate shredded iceberg lettuce supplied by Taylor Farms in central Mexico as the likely source of a multistate cyclospora outbreak, despite retracting a falsely positive laboratory result from a Taylor Farms sample. Taylor Farms recalled 25 lettuce and salad-mix products sold under eight brand codes, while the FDA expanded traceback efforts and began testing produce entering the United States. The outbreak has sickened at least 1,645 people and hospitalized 141 in 2026, although investigators face difficulties establishing a direct biological link between contaminated produce and illnesses.

The U.S. Food and Drug Administration approved Merck’s Lipfendra, the first noninjectable drug designed to block the cholesterol-regulating protein PCSK9. In clinical trials involving high-risk patients already receiving standard treatment, including statins, the pill reduced LDL cholesterol by more than 55%, with side effects comparable to placebo. It must be taken on an empty stomach and could expand access to PCSK9 treatment, which has previously been limited by the cost and prescribing barriers associated with injectable drugs.

Trump administration officials are seeking to make testosterone easier to prescribe, including for age-related symptoms such as low libido and erectile dysfunction. Recent studies found no increased rate of major cardiovascular events and modest benefits for sexual health, but little improvement in fatigue, memory or overall well-being. Experts warn that testosterone remains inappropriate for men seeking fertility treatment and requires caution in patients with prostate-cancer risks. They also emphasize the danger of overprescribing, inadequate screening by online providers and the lack of long-term data on conditions such as prostate cancer.

Utah’s launch of Doctronic, an AI system authorized to independently refill prescriptions, has triggered concerns among physicians and regulators over safety, oversight and compliance with state and federal medical laws. The program operates under Utah’s regulatory sandbox, allowing AI-driven prescription renewals with limited physician involvement and plans to transition to full automation. Medical boards and the American Medical Association warn that automated renewals can miss changes in patient health, while the FDA has taken a hands‑off stance despite questions about its regulatory role. Several states are easing AI healthcare restrictions, backed by pro‑AI policy groups, while critics argue that insufficient evidence and oversight risk patient safety and public trust.

U.S. health officials preparing to review the safety and effectiveness of peptide drugs will rely on a new FDA advisory panel that includes several clinicians and pharmacists with commercial ties to the peptide industry. The panel shifts away from previous academic-focused groups and aligns with efforts by Health Secretary Robert F. Kennedy Jr. and allies to reshape federal health policy in line with the Make America Healthy Again movement. Many peptides under review, including BPC-157 and TB-500, remain unapproved, carry safety concerns and are sold by compounding pharmacies and wellness clinics despite limited evidence. The panel’s composition raises conflict-of-interest concerns amid broader disputes over expert advisory bodies, following Kennedy’s earlier replacement of the CDC vaccine panel and criticism of FDA oversight structures.

U.S. health advisers are reviewing Moderna’s mRNA flu vaccine, mFlusiva, for potential FDA approval for adults 50 and older. Clinical data from a 40,000‑person trial showed a 27 percent reduction in flu cases compared with a standard vaccine, and a smaller study found antibody responses comparable to a high‑dose senior vaccine. The FDA’s initial internal dispute over study design was resolved, and the agency has reported no safety concerns, though it noted limited data for frail and immunocompromised older adults. An advisory panel’s evaluation will influence the FDA’s decision ahead of the winter flu season.

Cases of alpha‑gal syndrome are increasing in the U.S. due to expanding tick habitats and greater awareness among clinicians. The condition is triggered by antibodies formed after certain tick bites, leading to allergic reactions when consuming mammalian meat or, in some cases, dairy. Diagnosis relies on blood tests combined with reported symptoms, though false positives occur. Management focuses on avoiding triggering foods, preventing new tick bites, and considering emerging treatment options such as the FDA‑approved drug Xolair. Genetically modified GalSafe pigs offer a rare meat option without alpha‑gal, and some medical implants may pose risks for patients with the syndrome.

Alpha-gal syndrome, a growing allergy caused by tick bites, triggers reactions to mammalian meat and sometimes dairy when the immune system develops antibodies to the alpha-gal sugar. Rising diagnoses reflect broader awareness and the expanding range of lone star ticks. Symptoms include hives, digestive issues and potentially life-threatening reactions, with diagnosis based on blood tests and clinical history. Treatment focuses on avoiding mammal products and preventing new tick bites, though the FDA recently approved Xolair to reduce severe reactions. Genetically modified GalSafe pigs offer a rare meat option for some patients, and researchers continue exploring additional therapies.

An FDA memo reveals that fruit‑flavored e‑cigarettes from Glas Inc. were no more effective at helping adults quit smoking than tobacco flavors, despite being approved as less harmful alternatives. The approval contradicts previous FDA standards requiring strong evidence for youth‑appealing flavors and omits details typical in authorization documents. Lawmakers and health groups are scrutinizing the decision, which followed internal disagreements and occurred shortly before the FDA commissioner’s resignation amid industry pressure over vaping regulations.

FDA authorization of fruit‑flavored e‑cigarettes from Glas Inc. drew criticism after internal documents showed the products did not significantly outperform tobacco flavors in helping adults quit smoking. The memo released by the agency was unusually brief and lacked key study details, prompting further scrutiny from lawmakers. Regulators justified the authorization by citing low youth appeal due to age‑verification features, despite prior guidance that fruit flavors required strong evidence to offset risks to minors. The decision followed a contentious review process involving reversals within the FDA and pressure from political and industry stakeholders, leading to calls from Democratic senators for additional information.

The FDA has approved bemotrizinol, marking the first approval of a new U.S. sunscreen ingredient in more than 25 years. Already widely used in Europe and other countries, the ingredient protects against both UVA and UVB rays while reportedly causing minimal irritation and absorption. Dutch manufacturer DSM Nutritional Products plans to launch it in the United States under the brand name Parsol Shield, with an 18-month period of exclusivity. The approval followed a streamlined process authorized by Congress in 2020 and could help modernize the U.S. sunscreen market.

U.S. federal regulators have approved bemotrizinol, the first new sunscreen ingredient authorized in the country in more than 25 years. Sold initially by DSM Nutritional Products under the brand name Parsol Shield, the ingredient protects against both UVA and UVB radiation, causes minimal skin irritation and is approved for adults and children aged six months and older. The approval follows a streamlined process created by Congress in 2020; other manufacturers can use the ingredient after an 18-month exclusivity period. The decision addresses criticism that U.S. consumers have lacked access to sunscreen technology available in Europe since 1999, while further FDA proposals on SPF limits and stronger UVA protection remain unfinished.

U.S. regulators approved bemotrizinol, the first new sunscreen ingredient in more than 25 years, concluding it protects against UVA and UVB rays with minimal irritation or absorption. The ingredient will debut as Parsol Shield, produced by DSM Nutritional Products, before becoming available to other manufacturers after an exclusivity period. Experts say it addresses gaps in U.S. sunscreen options, offering broad-spectrum protection without the residue associated with mineral formulas. The move follows a streamlined FDA review process established in 2020 and continues broader efforts to update sunscreen standards.

FDA tobacco officials were surprised by new guidance allowing certain nicotine products to enter the U.S. market without full authorization, a policy issued shortly before Commissioner Marty Makary’s resignation. The move bypassed usual expert input and the public comment process, prompting internal confusion and concern about transparency. The guidance broadens enforcement discretion for unauthorized e‑cigarettes and may permit new flavored products, shifting focus toward targeting youth‑appealing designs rather than flavors alone. Larger tobacco companies are expected to benefit due to their ability to advance applications through scientific review, while smaller firms fear competitive disadvantages. Experts note the policy represents a significant departure from FDA precedent amid an already saturated market of unauthorized flavored vapes.

A top Food and Drug Administration drug-program leader, Dr. Tracy Beth Hoeg, is stepping down amid a broader reshuffling that has seen multiple senior officials resign, including FDA Commissioner Marty Makary and vaccine chief Vinay Prasad. Hoeg, aligned with Makary and Health Secretary Robert F. Kennedy Jr., rose rapidly within the agency and led investigations into vaccine safety, antidepressant risks and RSV drug concerns. Her tenure drew scrutiny due to past public criticism of pandemic measures and involvement in controversial vaccine-related analyses. The shake-up follows pressure on the FDA from political allies of former President Donald Trump. Replacements have been named for key leadership roles as the agency continues navigating internal disputes and external criticism.

The U.S. Supreme Court ruled to maintain access to mifepristone while ongoing litigation continues, allowing the abortion medication to remain available through pharmacies and by mail without in‑person doctor visits. The decision blocks lower‑court restrictions as drug manufacturers and the FDA pursue an appeal, keeping current access in place at least into next year.

Multiple senior vacancies across U.S. health agencies have expanded following the resignation of FDA chief Marty Makary, intensifying concerns over instability and diminished scientific leadership within the Department of Health and Human Services. Critics argue that turnover, political interference, and staffing choices under Secretary Robert F. Kennedy Jr. have weakened agencies such as the FDA and CDC during ongoing public health challenges. The FDA faces unresolved regulatory initiatives, while the CDC continues to navigate a series of short-term directors and reduced communication capacity. Recent White House shifts in health policy messaging and new nominations signal potential changes in direction, though experts warn that leadership gaps and ideological pressures continue to undermine confidence in federal health oversight.

The Supreme Court has temporarily preserved access to mifepristone by delaying the implementation of restrictions imposed by a federal appeals court. Justice Samuel Alito’s order allows patients to continue obtaining the medication through pharmacies, mail and telehealth while the court considers a challenge brought by Louisiana against the FDA’s prescribing rules. The case is part of broader litigation over abortion access following the overturning of Roe v. Wade; medication abortions accounted for nearly two-thirds of U.S. abortions in 2023.

The Supreme Court extended temporary access to mifepristone while it considers potential restrictions arising from a Louisiana-led legal challenge. The order delays a federal appeals court ruling that sought to suspend mail access and telehealth prescriptions for the drug. The case follows earlier disputes over mifepristone and comes amid ongoing efforts by abortion opponents to challenge its safety and regulatory approval. Medical groups, pharmaceutical companies and Democratic lawmakers warn that limiting access could undermine drug approval processes. Political sensitivities persist as the issue intersects with state abortion bans and national electoral considerations.

FDA leaders under the Trump administration have announced major policy changes through media appearances and informal statements rather than formal rulemaking, including actions on synthetic food dyes and COVID-19 vaccine approvals. Experts say the agency has not provided scientific documentation to justify some shifts and has bypassed advisory panels, while industry has offered limited resistance despite FDA’s significant influence over product approvals. Some initiatives may benefit companies, though changes lacking formal rulemaking may be easily reversed by future administrations. Emerging signs of pushback include a drugmaker’s petition challenging the FDA’s release of rejection letters.

The FDA authorized its first fruit‑flavored e‑cigarettes for adult smokers, marking a significant regulatory shift following appeals from the vaping industry amid declining teen vaping rates. Glas Inc. received approval to market mango, blueberry and menthol flavors supported by strict digital age‑verification controls. Health groups warn of youth risks, while industry advocates push for broader acceptance of flavors. The decision contrasts with the Biden administration’s earlier denials of most flavored vape products and follows evolving FDA guidance on adult‑oriented flavors. Unauthorized fruit and candy vapes remain widely used by teens despite being illegal.

The FDA has awarded priority review vouchers to companies developing psilocybin treatments for difficult-to-treat depression and methylone for PTSD, potentially shortening review timelines from months to weeks. It has also authorized early testing of a DemeRx drug derived from ibogaine for alcohol use disorder, despite ibogaine’s known cardiac risks. The moves follow Donald Trump’s executive order to accelerate psychedelic research and access, with advocacy from figures including Joe Rogan and Robert F. Kennedy Jr. The policy is likely to face scrutiny over whether political connections are influencing the FDA’s voucher program, while growing numbers of drug developers pursue psychedelic medicines that remain federally classified as Schedule I substances.

Psychedelic retreats are expanding worldwide as people seek psychological healing and personal growth, but the industry has few common safety standards. In the United States, most retreat drugs remain federally illegal, while the FDA has been directed to accelerate reviews of potentially therapeutic psychedelics. Researchers and clinicians warn that screening, staffing, emergency planning and post-experience support vary widely. Nearly 90% of surveyed retreats require or recommend stopping medications such as antidepressants, often for periods shorter than medically supervised tapering requires, potentially increasing the risk of symptom relapse or other harm.

Donald Trump signed an executive order directing federal agencies to accelerate research and potential approval of psychedelic drugs, including ibogaine. The FDA plans to issue priority vouchers for three psychedelics and is preparing for possible human trials of ibogaine, which advocates say could help veterans with PTSD and people with opioid addiction. Researchers warn that ibogaine can cause dangerous heart-rhythm problems and has been linked to more than 30 deaths, while existing studies remain small and lack rigorous controls. The order could increase federal and state support for research, but ibogaine remains unapproved, illegal under federal law and generally unavailable through insurance.

The FDA plans to ask outside pharmacy advisers in July whether seven peptides, including BPC-157 and TB-500, should be moved to a category allowing routine compounding. The proposal follows Health Secretary Robert F. Kennedy Jr.’s support for peptides and criticism of Biden-era restrictions, despite FDA warnings that most of these substances lack extensive human testing and may pose risks including cancer and organ damage. Wellness influencers, clinics, compounding pharmacies and some lawmakers argue that restrictions have fueled an unregulated overseas market, while critics point to unsupported health claims, doping bans and the absence of reliable safety standards.

Raw Farm is recalling seven varieties of raw-milk cheddar cheese sold nationwide while the FDA investigates an E. coli outbreak linked to the company’s products. Nine people, including children, have reportedly been sickened, and genetic testing indicates a common source; seven of eight interviewed patients reported consuming Raw Farm products. The company says it is conducting the voluntary recall “under protest,” noting that the FDA has not detected E. coli in its products. The recall covers specific cheddar blocks and shredded products with expiration dates from May through September 2026.

Dietary supplement makers are urging the FDA to broaden its definition of permissible supplement ingredients to include substances such as peptides and certain probiotics. The industry argues that current rules create costly uncertainty, while FDA lawyers say some products containing these ingredients violate existing requirements. Robert F. Kennedy Jr.’s support for peptides has encouraged supplement advocates, but former regulators and consumer advocates warn that the industry already faces limited FDA oversight and can make broad health claims without the rigorous evidence required for drugs. A 2024 Supreme Court decision could also make any regulatory dispute more likely to reach the courts.

Federal regulators warned ImmunityBio after Patrick Soon‑Shiong made unsupported claims on a podcast and in a TV ad that the company’s bladder cancer drug Anktiva could treat, cure or prevent multiple cancers. The FDA said the statements were misleading, lacked required risk information and falsely referred to the drug as a cancer vaccine. Shares of ImmunityBio dropped following publication of the warning, and the agency gave the company 15 days to respond. ImmunityBio stated it will work with regulators to address the issues.

The FDA approved leucovorin for children and adults with an ultrarare genetic condition that prevents folate from reaching the brain, but narrowed the decision after reviewing evidence related to autism. Earlier claims by Donald Trump and administration officials that the drug might help a large share of autistic children were not supported by the strongest available research, including a retracted study. Medical organizations say evidence for use in autism remains limited, while prescriptions rose sharply after the administration's September announcement, creating supply pressures that the FDA is addressing through imports.

FDA drug chief Tracy Beth Hoeg is working to hire her colleague Adam Urato, who is simultaneously petitioning the agency to issue strong new warnings on antidepressant use in pregnancy. The collaboration has raised conflict-of-interest concerns within the FDA, as Hoeg has pushed to accelerate the petition’s review despite its reliance on limited evidence. External experts warn that the proposed warning could endanger pregnant women by discouraging needed treatment. Hoeg’s actions fit into a pattern of controversial positions and alignments, including ties to COVID-19 policy critics and figures elevated by Robert F. Kennedy Jr. Researchers caution that studies cited in the petition often fail to account for underlying health factors that influence pregnancy outcomes and developmental disorders, emphasizing the continued need for balanced treatment options during pregnancy.

AI chatbots designed for health-related questions, such as ChatGPT Health and Claude, can provide personalized explanations of medical data but are not substitutes for professional care. Experts warn users to avoid chatbots during medical emergencies and remain cautious even in non-urgent cases due to risks of incorrect or mixed-quality information. Privacy concerns arise because health data shared with AI companies is not protected under HIPAA. Early testing shows chatbots excel at identifying conditions from structured data but struggle during real interactions, largely due to communication issues. Using multiple chatbots for comparison may improve confidence in responses.

The FDA will pilot a bonus program that rewards drug reviewers who complete evaluations ahead of schedule, aiming to improve efficiency amid staffing losses and criticism over recent regulatory decisions. The initiative ties payments to time savings, work quality, and complexity, while senior officials emphasize that speed should not compromise safety. The plan raises ethical and perception concerns as the agency continues to face scrutiny over its alignment with industry and tightening review standards, highlighted by recent disputes involving clinical evidence requirements and Moderna’s mRNA flu shot application.

Federal health officials proposed a new FDA pathway to support customized therapies for rare diseases, enabling experimental treatments based on a plausible biological mechanism where large clinical trials are impractical. The proposal would create a standardized authorization process with potential commercialization options, addressing limitations of the current compassionate‑use system. The initiative reflects ongoing shifts in FDA standards and highlights recent advances in individualized gene‑editing therapies such as CRISPR.

The FDA will shift from requiring two clinical trials to a single-study standard for most new drug approvals, a move aimed at accelerating access to treatments. Commissioner Marty Makary and deputy Vinay Prasad argue that modern research methods make duplicate trials unnecessary. The change aligns with decades of increasing flexibility for serious diseases but will now extend to common conditions. Former FDA drug chief Janet Woodcock supports the scientific rationale but notes uncertainty about how the policy will be implemented. The shift comes amid contrasting FDA actions on vaccines and gene therapies, including recent decisions affecting Moderna, contributing to uncertainty within the biotech industry.

The FDA rejected Moderna’s application for a new mRNA-based flu vaccine, citing inadequate trial design that failed to compare the shot against the best available standard for older adults. The agency noted that Moderna did not follow prior guidance on trial methodology, though Moderna said the FDA had allowed the study to proceed and raised no safety concerns. The company has requested an urgent meeting and is pursuing approvals in other countries. The decision reflects broader policy shifts under Health Secretary Robert F. Kennedy Jr., including increased scrutiny of mRNA vaccines and changes to COVID‑19 vaccine recommendations.

Hims & Hers plans to release a low‑cost compounded version of the new Wegovy pill, prompting Novo Nordisk to threaten legal action and call the product an unapproved imitation. Despite FDA warnings about misleading marketing, Hims continues offering compounded GLP‑1 drugs, citing personalization exemptions that allow compounding after official shortages end. The company will price its pill below Novo Nordisk’s, while regulators and the drugmaker challenge the legitimacy and safety of compounded alternatives. Novo Nordisk shares dropped more than 5% following the announcement.

A House lawmaker raised new concerns about the FDA’s expedited drug review program, questioning the transparency, legal authority and ethics compliance of senior officials involved in determining which drugs receive priority vouchers. Rep. Jake Auchincloss highlighted the absence of responses to congressional inquiries and the FDA’s failure to release required financial disclosures for key decision-makers. FDA leaders emphasized in an internal town hall that final drug approval decisions remain with agency scientists. Previous inquiries from other lawmakers, including Sen. Bernie Sanders and Rep. Frank Pallone, also went unanswered. The scrutiny underscores broader concerns about shifting decision-making power away from career scientists and the legal basis for the initiative.

Altria reported lower fourth‑quarter revenue as cigarette sales continued to decline and competition intensified in newer nicotine products, particularly pouches. Market share for its on! brand fell while Philip Morris International’s Zyn remained dominant. The company discussed pricing strategy and expansion plans for its nicotine pouches, while also noting setbacks in its e‑cigarette business following a patent ruling that halted NJOY Ace sales. Adjusted earnings missed expectations, though adjusted revenue slightly exceeded forecasts, and full‑year earnings guidance remained unchanged.

The FDA is reviewing Philip Morris International's request to market Zyn nicotine pouches with reduced‑risk claims compared with cigarettes. Preliminary agency analysis indicates support for the proposal, citing evidence that Zyn contains far fewer harmful chemicals than traditional tobacco products. Zyn dominates the fast‑growing nicotine pouch market, generating billions in sales, though overall usage among U.S. adults and teens remains low. Regulators are also weighing concerns about youth exposure and viral social media content. An FDA advisory panel will review the evidence and provide recommendations, though the agency will make the final decision.

A new FDA fast‑track drug review program under Commissioner Marty Makary has triggered internal turmoil, with staff and experts raising legal and scientific concerns about shifting approval authority from career scientists to political leadership. Multiple senior officials have declined to sign off on expedited approvals due to unresolved questions over legal responsibility. The program has become linked to White House drug pricing announcements, prompting fears of political interference. Reviewers report pressure to accelerate timelines and overlook regulatory steps, particularly in cases involving Eli Lilly’s obesity drug. The situation has contributed to staff departures, increased anxiety within the agency, and concerns that the FDA’s scientific integrity and patient safety standards are being undermined.

The FDA’s new expedited drug approval program has triggered internal concern over legal authority, scientific standards, and political interference. Reviewers report pressure to shorten evaluations and skip regulatory steps, while safety issues have already delayed some drug reviews. Senior officials, rather than scientific staff, have taken a central role in awarding and approving vouchers, raising questions about transparency and legality. The program has rapidly expanded despite staffing shortages and unclear rules, prompting fears that rushed approvals could expose the agency and individual reviewers to legal risk. Some experts argue the initiative exceeds scientific limits and may be reversed under a future administration.

At-home STI testing is expanding in the United States, with FDA-approved options for gonorrhea, chlamydia, trichomoniasis and HPV offering greater convenience, faster results and potentially quicker treatment. Visby Medical’s three-in-one test can provide results and telehealth follow-up within hours, while new oral drugs Nuzolvenc and Bluejepa offer alternatives to injectable ceftriaxone amid rising gonorrhea antibiotic resistance. STI rates declined in 2024, but experts caution that home testing may complicate national surveillance and that high prices, lack of insurance coverage and cuts to public-health funding could limit access for vulnerable populations.

Federal health officials proposed regulations that would bar gender‑affirming care for minors from receiving Medicaid, Medicare, and related federal funding, jeopardizing access in states where such treatments remain legal. The measures contradict guidance from major medical organizations and are expected to face legal challenges. Advocates warn the changes could deter providers and restrict care for transgender youth, while most U.S. hospitals risk losing essential federal payments if they continue offering such services.

U.S. regulators expanded approval of the libido‑boosting drug Addyi to include postmenopausal women, despite longstanding concerns about modest effectiveness and side effects such as dizziness and risks when combined with alcohol. The decision follows years of advocacy by Sprout Pharmaceuticals and its supporters, who argue for better treatment options for women with hypoactive sexual desire disorder. While the condition affects many women, experts differ on its classification, and diagnosing it remains complex. The FDA previously rejected Addyi twice before its 2015 approval, and sales have remained limited.

The FDA has launched a safety review of two injectable RSV antibody drugs for infants and toddlers made by Merck and Sanofi, though neither company reports new safety concerns. The review comes as health officials under Health Secretary Robert F. Kennedy Jr. reexamine vaccine policies and after sweeping changes to CDC advisory committees. Recent moves, including a recommendation to end routine hepatitis B vaccination for newborns, have drawn strong criticism from medical groups. FDA officials are also evaluating broader changes to vaccine oversight while continuing to review safety data for existing RSV antibody treatments.

FDA-approved Stellest lenses are being introduced in the U.S. to slow the progression of myopia in children aged 6 to 12. Studies show significant reductions in both myopia progression and eye elongation, potentially preventing severe long‑term complications such as retinal detachment and glaucoma. The lenses offer an alternative to existing contact lens treatments and may be preferred for younger children. Insurance coverage is expected, though some experts seek additional U.S.-based research to confirm results observed in Asia.

The FDA imposed a boxed warning and new restrictions on Sarepta’s gene therapy Elevidys after two patient deaths, limiting its use to ambulatory patients aged four and older and adding requirements for intensive liver monitoring. Shipments were briefly paused before resuming following pushback from families and activists. Sarepta, already facing financial strain and layoffs, saw its stock rise after the clarified regulatory stance.

Unapproved peptide injections have surged in popularity among influencers, wellness clinics and celebrities, despite lacking FDA approval and posing potential safety risks. Many peptides promoted for muscle building, skin improvement and injury recovery have not been studied in humans and are often illegally sold or inappropriately compounded. Experts warn that combining multiple peptides increases dangers. FDA regulators have tightened oversight, adding numerous peptides to lists of substances that should not be compounded. The trend has been amplified by prominent figures such as Jennifer Aniston, Joe Rogan and Robert F. Kennedy Jr., whose supporters link peptides to the Make America Healthy Again movement. Growing commercial incentives have pushed compounding pharmacies to continue producing unapproved products even after shortages of approved GLP-1 drugs ended.

Americans are increasingly using unapproved peptides promoted by influencers and allies of Robert F. Kennedy Jr., despite a lack of clinical evidence and regulatory concerns. The FDA has long attempted to restrict unsafe peptide products through warning letters and compounding bans, prompting backlash from wellness entrepreneurs and compounding pharmacies. Kennedy has vowed to end FDA enforcement against peptides, aligning with figures such as Gary Brecka who commercially promote them. Experts warn of safety risks, contamination, and unregulated imports from overseas manufacturers as demand grows. Recent legal challenges and advisory panel changes could shift regulatory oversight, while physicians report rising patient interest and advise caution regarding long-term safety.

The FDA will remove its long‑standing boxed warning from more than 20 hormone‑based menopause treatments, concluding that risks vary by age and formulation. The update aligns prescribing guidance with current recommendations that the drugs are most appropriate for younger women without complicating health conditions. Critics argue the agency bypassed its usual advisory process by consulting a group of experts largely supportive of hormone therapy, some with industry ties. The original warning content will remain but be moved to a less prominent position, while newer low‑dose products will receive distinct risk labels.

US regulators issued warnings to 18 websites selling counterfeit or unapproved Botox and similar injectable drugs after reports of injuries. The FDA cautioned that unapproved versions may pose serious risks and emphasized that only trained medical professionals should administer these products. Approved Botox treatments carry boxed warnings due to the potential for toxin spread and life‑threatening side effects such as botulism. Patients showing symptoms were urged to seek immediate medical care.

The FDA restricted fluoride supplements for children, advising against their use in kids under three and in older children without high cavity risk. A new agency analysis found limited dental benefits and potential safety concerns, prompting warnings to manufacturers and health providers. The American Dental Association disputed the concerns, while some dentists warned the restrictions could worsen dental outcomes in rural areas lacking fluoridated water. Robert F. Kennedy Jr.’s department has taken a critical stance on fluoride, including efforts to end water fluoridation. Other fluoride dental products, such as toothpaste and mouthwash, remain unaffected.

Federal regulators introduced draft guidance intended to simplify biosimilar drug development by reducing study requirements, aiming to encourage competition and lower prices for costly biologic medicines. The proposal begins a public comment period before revision and finalization, and while nonbinding, is expected to guide drugmakers. Expanded biosimilar use has the potential to ease patient expenses over time, though immediate savings depend on insurance coverage and formulary placement.

The Food and Drug Administration selected nine experimental drugs for expedited review under a new program prioritizing treatments considered important to U.S. national interests. The list includes drugs for vaping addiction, deafness, pancreatic cancer and the infertility drug Pergoveris, which President Donald Trump said could lower IVF costs if approved. The program aims to deliver decisions within one to two months, far faster than standard review timelines. FDA Commissioner Marty Makary has advocated quicker approvals for high‑priority medicines, drawing on lessons from the COVID‑19 vaccine authorizations, while the program’s broad criteria give FDA leaders significant discretion in selecting qualifying products.

A cannabis-derived medication developed by Vertanical reduced chronic lower‑back pain in an 800‑patient study, showing statistically significant improvements over placebo and additional benefits in sleep and physical function. Side effects led to a lower discontinuation rate than typically seen with opioids. The THC‑containing liquid extract is being submitted for approval in Europe, and the company is working on a study design to seek FDA approval in the United States, highlighting ongoing interest in cannabis-based treatments amid limited options for chronic pain.

Trump administration approval of leucovorin as an autism treatment prompted concern from researchers who say evidence supporting its use is limited and inconsistent. Experts including Richard Frye, who originally proposed further study of the drug, were surprised by the rapid move to endorse the decades‑old medication without additional trials. Autism specialists warn that small, early studies are insufficient to justify broad clinical use and emphasize uncertainties about folate‑related mechanisms in autism. Federal discussions involving Frye and health officials had focused on developing a new proprietary formulation, but the FDA instead chose to update labeling for existing generics, likely boosting prescriptions. While online interest grows and some parents report anecdotal improvements, researchers urge caution and call for rigorous, controlled studies to determine effectiveness and safety.

Federal health officials issued more than 100 warning letters targeting telehealth companies such as Hims for promoting compounded versions of prescription drugs with misleading claims, including comparisons to FDA‑approved weight‑loss medications like Wegovy and Ozempic. The effort follows a directive from President Donald Trump emphasizing truthful pharmaceutical advertising. The FDA criticized Hims’ promotional statements and past advertisements for omitting safety information. Additional letters addressed advertising issues related to other products, including AstraZeneca’s FluMist. Regulators noted that compounded GLP‑1 drugs should no longer be produced except in customized cases after determining that shortages have ended, while medical groups continued to warn that persuasive drug advertising fuels unnecessary demand.

The administration directed the FDA and other agencies to intensify enforcement against misleading prescription drug advertising, though legal challenges, reduced staffing and lengthy rulemaking processes pose major obstacles. The FDA issued broad compliance warnings to drugmakers following years of diminished enforcement driven by legal setbacks and caution around court precedent. Plans to revise long‑standing rules governing TV advertisements could take years and face industry resistance. Efforts to regulate social‑media drug promotion are limited by jurisdictional constraints over influencers and telehealth companies, while proposed legislation to expand FDA authority has stalled.

Experts warn that unreliable Lyme disease tests and unproven treatments are expanding, driven by diagnostic uncertainty, social media influence and high patient demand. Only antibody blood tests are FDA‑approved, leaving alternative tests and costly therapies to fill the gap despite lacking evidence and sometimes causing harm. Specialists highlight risks from long‑term antibiotic use and other experimental procedures and call for more research into persistent symptoms experienced by some Lyme patients while cautioning against profiteering clinics and inaccurate testing methods.

U.S. senators from both parties sharply questioned Robert F. Kennedy Jr. during a tense Senate Finance Committee hearing focused on vaccine policy, the dismissal of CDC director Susan Monarez, and recent changes limiting access to COVID-19 vaccines. Kennedy disputed criticism from lawmakers, dismissed scientific consensus on several issues, and engaged in confrontations with multiple Democratic senators. Both Democrats and Republicans raised concerns about vaccine access, CDC leadership changes, and Kennedy’s public statements, while Republicans also pressed him on the effectiveness of Operation Warp Speed. The session highlighted bipartisan unease with his handling of vaccine policy and public health messaging.

A midstage study by Mindmed found that a single supervised dose of LSD reduced anxiety symptoms in patients with generalized anxiety disorder, with effects lasting up to three months and the highest dose putting nearly half of participants into remission. The research, published in the Journal of the American Medical Association, avoided combining the drug with therapy to address earlier methodological concerns raised by the FDA in psychedelic trials. While results were positive, issues such as unblinding, participant dropout, and unclear long‑term effects remain. Mindmed plans larger late‑stage trials as interest in psychedelic therapies grows among U.S. health officials.

Updated COVID-19 vaccines from Pfizer, Moderna and Novavax were approved for seniors while access for younger groups was restricted to those with qualifying health risks, with Pfizer’s shot removed for children under five. Medical groups warned the limits could reduce access for families seeking vaccination, and insurers and state rules may further complicate distribution. The changes follow leadership skepticism about broad annual vaccination, and new CDC advisory panel decisions will determine coverage and documentation requirements. Updated vaccines target a newer variant, and several older pandemic-era authorizations were withdrawn as regulators emphasized protection against severe disease, especially for high‑risk groups.

FDA Commissioner Marty Makary has initiated informal expert panels that critics argue bypass established transparency rules and elevate fringe or litigation-linked viewpoints on topics such as talc, antidepressants and hormone therapy. Former FDA officials and medical organizations warn that the panels feature financial conflicts, unsubstantiated claims and predetermined positions aligned with Robert F. Kennedy Jr.’s views. Concerns center on potential misuse of the panels’ discussions in legal contexts, deviations from scientific consensus and the lack of balanced, conflict-screened advisory committee oversight.

Robert F. Kennedy Jr. plans major changes to the federal Vaccine Injury Compensation Program, raising concerns among health experts that he may expand eligibility to unproven vaccine-related conditions such as autism. Experts warn such changes could overwhelm the program and destabilize U.S. vaccine infrastructure. Kennedy has brought in advisers with histories of litigating vaccine injury claims, including attorney Andrew Downing, who has led lawsuits against Merck’s Gardasil. The program, created in 1986, has long delays, outdated compensation caps, and limited adjudication capacity, prompting broad agreement that reform is needed. Potential changes include adding new injuries like autism or removing vaccines from the program, which could expose manufacturers to civil lawsuits. Specialists caution that these moves could undermine public health and increase vaccine costs, while attorneys argue that modest reforms could make the program more accessible and efficient.

U.S. regulators issued alerts on two Boston Scientific heart devices, citing electrical failures in Endotak Reliance defibrillator wires tied to hundreds of injuries and multiple deaths, and implantation risks associated with the Watchman stroke‑prevention device. Updated instructions warn of increased blockage risk during implantation depending on anesthesia use. The company reported significant injury and death totals for both devices while stating that the Watchman issue is unrelated to product design. Boston Scientific’s heart‑device business remains its largest revenue source, and its stock fell modestly following the notices.

Federal health regulators are urging a nationwide ban on 7-hydroxymitragynine, a potent opioid-like component of kratom increasingly found in energy drinks and supplements. The FDA recommends placing the ingredient on the federal Schedule I list, citing risks of addiction, injury and death. Supplement manufacturers selling traditional kratom support the crackdown on synthetic versions, while the American Kratom Association continues advocating against stricter regulation. The DEA will review the FDA’s recommendation as federal scrutiny of kratom and similar unapproved drugs intensifies.

U.S. regulators lifted a pause on shipments of Sarepta Therapeutics’ gene therapy Elevidys for ambulatory Duchenne muscular dystrophy patients after determining a recent child’s death was unrelated to treatment. The move follows earlier deaths among older patients that triggered regulatory scrutiny and halted distribution. Shares of Sarepta rose sharply on the decision, which analysts say improves near‑term sales prospects. The FDA continues to require additional safety data before allowing use in non‑ambulatory patients, who remain under a voluntary hold.

Sarepta Therapeutics agreed to halt shipments of its Duchenne muscular dystrophy gene therapy Elevidys after the FDA requested a pause following multiple patient deaths. The reversal came days after the company initially resisted regulators, prompting investor concern and ongoing share declines. The therapy, previously approved for both ambulatory and non‑ambulatory patients, has been under scrutiny due to serious liver injury cases. Analysts judged compliance with the FDA as necessary to preserve the company’s regulatory relationship, with the pause expected to last several months.

The FDA has appointed Dr. George Tidmarsh, a former pharmaceutical executive and cancer and pediatric specialist, to lead its Center for Drug Evaluation and Research. He will oversee the review of drug safety and effectiveness, including the agency's planned scrutiny of mifepristone and certain antidepressant and hormone-replacement uses. The appointment follows the retirement of acting director Jacqueline Corrigan-Curay and comes amid extensive turnover and workforce reductions under FDA Commissioner Marty Makary and Health Secretary Robert F. Kennedy Jr. About 2,000 FDA employees have been laid off and more than 1,000 have accepted buyouts or early retirement, raising concerns about delays to drug reviews and other core operations.

Sarepta Therapeutics told the FDA it would not halt all shipments of Elevidys, its gene therapy for Duchenne muscular dystrophy, despite the agency’s request after a third patient death linked to liver injury. The company plans to keep the treatment available for younger patients while shipments to older patients remain suspended. The FDA has placed a separate Sarepta gene-therapy trial on hold and could ultimately pursue a formal market withdrawal. The deaths, regulatory scrutiny, criticism over disclosure practices and the company’s planned layoffs have sharply damaged Sarepta’s stock and cast doubt on Elevidys’s future.

The FDA has allowed Juul to continue selling its reusable tobacco- and menthol-flavored e-cigarettes, concluding that the products may reduce exposure to harmful chemicals for adult smokers who switch completely from traditional cigarettes. The decision follows the agency’s reversal of a 2022 marketing denial after Juul challenged the review in court, but it is not an endorsement and the FDA continues to warn nonsmokers and young people against vaping. Juul, once valued at more than $13 billion, has faced sweeping criticism, job cuts, investigations and billions of dollars in settlements over its contribution to youth vaping. The company hopes to secure authorization for newer devices and additional flavors, while regulators report that teen vaping has declined and unauthorized flavored disposables remain a concern.

The Trump administration’s support for psychedelic therapy, led by Health Secretary Robert F. Kennedy Jr., has energized advocates but raised concerns that accelerated approvals could outpace the evidence and damage the field’s credibility. The FDA is reconsidering MDMA and exploring faster, more flexible review pathways, while Texas has committed $50 million to ibogaine research for opioid addiction, PTSD and related conditions. Supporters cite promising personal experiences and potential therapeutic benefits, but researchers warn that ibogaine’s cardiovascular risks and weaknesses in psychedelic trial design require rigorous evaluation before approval.

FDA vaccine chief Vinay Prasad overruled agency staff recommendations that updated Moderna and Novavax COVID-19 vaccines be approved for everyone aged 12 and older, limiting them instead to seniors and people at higher risk from COVID-19. Prasad cited declining death and hospitalization rates and concerns about rare vaccine side effects, particularly myocarditis. FDA reviewers concluded that the vaccines’ benefits outweighed their risks, while outside researchers noted that myocarditis associated with COVID infection can be more severe. The decisions are part of broader vaccine restrictions under Health Secretary Robert F. Kennedy Jr., including plans to limit future COVID booster approvals to higher-risk Americans.

The FDA has required Pfizer and Moderna to expand warnings about myocarditis, a rare heart inflammation associated mainly with COVID-19 vaccination in males aged 12 to 24. The updated labeling cites eight cases per million recipients of the 2023–2024 vaccines among people aged 6 months to 64 years, while noting that cases generally resolve quickly and are less severe than myocarditis caused by COVID-19 infection. The change comes as a newly appointed CDC vaccine advisory panel debates continued vaccination for groups including children and pregnant women. Outside experts criticized the labeling approach, arguing that officials should focus on identifying people most vulnerable to myocarditis rather than using broader warnings to restrict vaccine use.

The FDA plans to offer a limited number of national priority vouchers that could reduce reviews of selected medicines to one or two months, compared with roughly six months for accelerated approvals and ten months for standard reviews. The program would provide additional agency communications, streamlined reviews and advance submission of product information, but its broad eligibility criteria would give officials substantial discretion. Commissioner Marty Makary has advocated faster reviews and, in some cases, less reliance on randomized trials, prompting concerns because some drugs approved on preliminary evidence have later failed to demonstrate patient benefits. The initiative contrasts with Health Secretary Robert F. Kennedy Jr. and Makary’s stricter approach to vaccine approvals, including placebo comparisons and new testing for seasonal COVID-19 updates.

Sarepta Therapeutics reported a second teenage patient death from acute liver injury associated with Elevidys, its gene therapy for Duchenne muscular dystrophy. The company paused shipments to older non-ambulatory patients and a related study, while convening an expert panel to recommend stronger safety protocols, potentially including more immune-suppressing medication. The Food and Drug Administration is reviewing the situation, and analysts speculated that it could impose additional restrictions or withdraw the therapy for non-ambulatory patients. Sarepta’s shares fell more than 42%, adding to concerns about the treatment’s safety, effectiveness and accelerated regulatory approval.

Tianeptine products marketed as brightly colored energy shots or cognitive supplements at gas stations, convenience stores and smoke shops are increasingly being called “gas station heroin.” The drug is not FDA-approved in the United States and can be addictive, cause opioid-like effects, dangerously suppress breathing and trigger seizures and other serious reactions. Poison-control calls involving tianeptine rose 525% from 2018 to 2023, with many cases requiring medical or critical care. Experts warn that products may contain inconsistent doses or undisclosed substances, as in the Neptune’s Fix outbreak, which involved synthetic cannabis and other drugs. Although tianeptine is not federally controlled, roughly a dozen states have restricted it; Alabama saw calls decline modestly after a 2021 restriction while cases continued rising elsewhere.

Calley Means, a senior adviser to Health Secretary Robert F. Kennedy Jr., promotes policies and messaging that criticize prescription drugs and favor wellness alternatives while co-owning Truemed, a platform selling supplements and other products and helping users spend tax-free HSA funds. Because he is a special government employee, his financial disclosures are not publicly available, raising concerns about conflicts of interest. Means says his government work has not involved Truemed or HSAs and is focused on broader Make America Healthy Again goals. The Associated Press also found that he promoted his own book and products from business associates, including Function Health testing and Mark Hyman’s supplements. Economists and policy experts question expanded HSA use, arguing that it has not reduced health spending and disproportionately benefits wealthy Americans; proposed expansions are projected to cost the federal government $180 billion over a decade.