FDA signals openness to Moderna flu vaccine and clears UniQure's Huntington's therapy as Eli Lilly acquires 4E Therapeutics
The U.S. Food and Drug Administration indicated it is receptive to Moderna's seasonal flu vaccine ahead of the upcoming advisory committee meeting, suggesting a smoother review path.
UniQure reported that the FDA has withdrawn its earlier objection to its experimental gene therapy for Huntington's disease, opening the way for the company to submit a formal approval application.
In a separate industry move, Eli Lilly completed its purchase of 4E Therapeutics, adding the smaller biotech's assets to its portfolio.
These actions highlight a period of regulatory flexibility and strategic consolidation that could shape upcoming developments in biotech and vaccine markets.
This writeup was produced by pharmadog from original reporting by STAT.
Original headline: “STAT+: FDA appears open to Moderna’s flu vaccine ahead of adcomm”
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