FDA Makes U-Turn Again On Moderna New Flu Vaccine Review, Stock Soars

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 ...