Brief: Scholar Rock Says FDA Determined Catalent Indiana Inspection Classification As OAI

Scholar Rock Holding

13/10/2025 15:05

Oct 13 (Reuters) - Scholar Rock Holding Corp SRRK.O:

SCHOLAR ROCK - NOVO NORDISK INFORMED, FOLLOWING FDA FORM 483 ISSUED TO CATALENT INDIANA, FDA DETERMINED INSPECTION CLASSIFICATION OF FACILITY IS OAI

SCHOLAR ROCK- CONTINUE TO WORK CLOSELY WITH NOVO NORDISK, HAVE REQUESTED TYPE A MEETING WITH FDA TO DISCUSS NEXT STEPS FOR RESUBMITTING BLA

Further company coverage: SRRK.O

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