FDA Monthly Preview: Key August Decisions to Watch
The FDA’s August 2026 Prescription Drug User Fee Act calendar includes target action dates for multiple investigational drugs and therapies. Moderna’s mRNA-1010 has an Aug 5, 2026 PDUFA date. Gilead’s bictegravir/lenacapavir has Aug 27. Lantheus’ MK-6240 has Aug 13. Other listed PDUFA dates cover programs from Capricor, BMS, Jazz, Savara, Ultragenyx, PharmaEssentia, Regeneron, Takeda, and Priovant.
