In this week’s recap, we cover three biotech stories that signal big shifts in regulation:

• FDA tightens Covid booster rules: The FDA announced it will now require vaccine makers to run new clinical trials if they want to market annual covid boosters to healthy Americans under 65. Older adults and high-risk groups, roughly 100–200 million people, will still get access without delay. The move signals a new, more cautious regulatory posture under Commissioner Marty Makary and CBER Director Vinay Prasad, aiming to limit unnecessary repeat dosing. While the market for boosters narrows, investors were reassured that revenue from high-risk populations remains secure.

• Novavax finally gets its Covid moment: After years of delay, Novavax finally landed full FDA approval for its covid vaccine, Nuvaxovid, for adults 65+ and high-risk individuals aged 12–64. It’s the first non-mRNA vaccine fully approved in the U.S., and the decision triggers a $175M milestone payment from commercialization partner Sanofi. Shares jumped 16% on the news, signaling renewed optimism for the company after a long road through emergency use authorization limbo.

• Psychedelic therapies get a regulatory tailwind: In a surprising shift, FDA Commissioner Makary said evaluating psychedelics like MDMA and psilocybin would be a “top priority” for Trump administration. His comments, aired in a NewsNation interview, signaled a willingness to fast-track reviews, especially for PTSD treatment in veterans. It’s a notable departure from the previous administration’s rejection of an MDMA-based therapy last year. Shares of MindMed, COMPASS Pathways, Atai, and Cybin all saw upward movement as investor confidence rebounded.

  Read our deep dive on this topic HERE.

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