FDA Approves Moderna's mRNA Flu Vaccine for Older Adults
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- Moderna received FDA approval for its mRNA-based influenza vaccine for older adults, the first licensed flu shot made using messenger RNA technology.
- Vinay Prasad, then the FDA's head of biologics, issued a rare "refusal to file" notice in February overturning career staff recommendations; a week after Moderna publicly disclosed displeasure, the decision was reversed and Prasad left the FDA at the end of April.
- Takeda's twice-daily orexin receptor agonist pill Orzeyful won FDA approval for narcolepsy, backing a drug class scientists hope will transform sleep-disorder treatment.
- Current narcolepsy therapies — stimulants and sodium oxybates — carry misuse risk and still leave patients feeling sleepy, a gap the orexin system may address by regulating sleep-wake cycles and boosting attentiveness and cognition.
- Drugmakers are now aiming to test orexin receptor agonists across a broader range of neuropsychiatric conditions where patients experience sleepiness and fatigue.
Why it matters: Moderna's approval puts the first mRNA flu vaccine on the U.S. market roughly six months after a top FDA official's refusal-to-file notice seemed to block it, validating the platform for flu. For Takeda, Orzeyful's approval opens a new drug class for narcolepsy — stimulants and sodium oxybates dominate today despite misuse risk — with broader pipeline aims across sleep and cognition disorders.
