Fraiser Kansteiner

The FDA approved Moderna’s mFlusiva, the first mRNA-based influenza vaccine authorized in the United States, for adults aged 50 and older. The decision follows an unusual refusal-to-file episode in February over the phase 3 trial’s use of a standard-dose comparator; the FDA later reversed that decision. MFlusiva received traditional approval for adults aged 50–64 and accelerated approval for those 65 and older, supported by two phase 3 trials and a required postmarketing confirmatory study. Moderna expects to offer the vaccine during the 2026–2027 respiratory virus season, while applications are under review in the European Union, Canada and Australia.

Amgen's second-quarter sales rose 10% to $10.1 billion as growth from Repatha and other products outweighed biosimilar pressure on Prolia and Xgeva. Repatha sales increased 37% to $953 million, supported by new cardiovascular-risk data, including findings in high-risk patients with diabetes and those without prior heart attacks or strokes. Amgen believes more aggressive LDL lowering will expand the drug's use beyond the end of the decade, despite potential biosimilar competition. Other growth drivers included Evenity, Tepezza, Krystexxa, Uplizna and Tavneos, although Tavneos faces uncertainty related to ongoing FDA engagement.

The FDA approved Novartis’ Pluvicto in combination with an androgen receptor pathway inhibitor for PSMA-positive metastatic hormone-sensitive prostate cancer, moving the radioligand therapy into an earlier treatment setting and nearly doubling its potential patient pool. In the PSMAddition trial, the combination reduced the risk of disease progression or death by 28% in the primary analysis and 33% in an updated analysis, while showing a favorable overall-survival trend and a safety profile consistent with prior use. The approval strengthens Novartis’ ambition for Pluvicto to reach $5 billion in peak sales, although the company recently withdrew a European application for a pre-chemotherapy indication.