PDUFA Date for Lenacapavir
Jun 30, 2025, 7:00:00 AM — fda decision
Summary
The FDA has set a PDUFA date for lenacapavir, a drug for HIV prevention, which is anticipated to be a significant milestone for Gilead.
Company
GILEAD SCIENCES INC (GILD)NASDAQ — Healthcare: Manufacturing, Drug Manufacturers - General: Biological Products (No Disgnostic Substances)
www.gilead.comSimilar Events
FDA PDUFA Target Action Date for EMPAVELI®
The FDA has set a PDUFA target action date of July 28, 2025, for the supplemental New Drug Application of EMPAVELI® for treating C3 glomerulopathy and IC-MPGN.
fda decisionFDA PDUFA Target Action Date for Paltusotine
The FDA has set a PDUFA target action date of September 25, 2025, for paltusotine's New Drug Application, marking a critical step towards its approval for acromegaly treatment.
fda decisionPDUFA Date for RP1
The FDA has set a PDUFA date of July 22, 2025, for Replimune's RP1, a significant milestone in the regulatory process for this oncolytic immunotherapy.
fda decisionPDUFA Target Action Date for LNZ100
The FDA has set a PDUFA target action date of August 8, 2025, for LNZ100, a treatment for presbyopia, with commercial launch activities expected to commence immediately upon approval.
fda decision