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FDA Makes U-Turn Again On Moderna New Flu Vaccine Review, Stock Soars
Benzinga· 2026-02-18 18:20
The stock’s movement comes after the U.S. Food and Drug Administration (FDA) notified Moderna that its biologics license application for mRNA-1010 will proceed to review, adding pressure as broader markets experienced mixed trading.Following a Type A meeting, the FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 5 for mRNA-1010, which is aimed at adults aged 50 and older.Pending review and FDA approval, mRNA-1010 would be available for U.S. adults 50 years of age and older, inclu ...