Brief: Merck Says FDA PDUFA Date For Subcutaneous Pembrolizumab Set For Sept 23

Halozyme Therapeutics

27/03/2025 15:00

March 27 (Reuters) - Merck & Co Inc MRK.N:

MERCK: INVESTIGATIONAL SUBCUTANEOUS PEMBROLIZUMAB WITH BERAHYALURONIDASE ALFA SHOWS NONINFERIOR PHARMACOKINETICS VERSUS IV KEYTRUDA IN 3475A-D77 TRIAL

MERCK: APPLICATIONS FOR SUBCUTANEOUS PEMBROLIZUMAB ARE UNDER REVIEW IN U.S. & EUROPE

MERCK: FDA HAS SET PDUFA DATE OF SEPT 23

MERCK EXEC SAYS WILL LAUNCH SUBCUTANEOUS KEYTRUDA AT RISK IF HALOZYME PATENT DISPUTE NOT RESOLVED YET - INTERVIEW

MERCK EXEC SAYS HOPES TO LAUNCH SUBCUTANEOUS KEYTRUDA ON OCT 1, SEES PEAK ADOPTION ABOUT 18-24 MONTHS AFTER APPROVAL - INTERVIEW

Further company coverage: MRK.N

 ((Reuters.Briefs@thomsonreuters.com;))