FDA Approves Moderna’s mFlusiva, the First mRNA-Based Seasonal Flu Vaccine

The FDA’s approval of Moderna’s mFlusiva, the first mRNA-based seasonal flu vaccine, alongside Takeda’s first-in-class narcolepsy drug Orzeyful, underscored a day of regulatory validation for novel mechanisms — while Amazon Pharmacy’s move to sell GLP-1 weight-loss drugs for $50 a month to eligible Medicare patients signaled how aggressively access economics are reshaping the sector’s largest commercial category.

Today’s top developments:

• The FDA approved Moderna’s mFlusiva (formerly mRNA-1010) for seasonal influenza in adults 50 and older — the first mRNA-based flu vaccine cleared in the US — completing a turnaround after the agency initially refused to review the application (BioPharma Dive)
• Takeda won FDA approval for Orzeyful (oveporexton), an orexin receptor 2 agonist for narcolepsy type 1 and the first medicine to target the disorder’s root cause, following two earlier OX2R stumbles (Fierce Pharma)
• Tarsus Pharmaceuticals agreed to acquire Alkeus Pharmaceuticals for up to $800 million — $450 million upfront — gaining a Phase 3 therapy for Stargardt disease, a rare inherited macular degeneration with no approved treatments (Pharmaphorum)
• Amazon Pharmacy said it will deliver GLP-1 weight-loss drugs including Wegovy and Zepbound KwikPen to eligible Medicare beneficiaries for $50 a month through a new federal bridge program running through 2027 (Reuters)
• AstraZeneca and CSPC agreed to form a biologics manufacturing joint venture in Shijiazhuang, China — CSPC holding 51% and AstraZeneca 49% — with output counting toward AstraZeneca’s $15 billion China investment pledge through 2030 (Fierce Pharma)