Genmab A/S (GMAB) Announces FDA Extension of sBLA Review, Submitted by Novartis (NVS), for Ofatumumab in Relapsing Multiple Sclerosis

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Go back to Genmab A/S (GMAB) Announces FDA Extension of sBLA Review, Submitted by Novartis (NVS), for Ofatumumab in Relapsing Multiple Sclerosis

U.S. FDA Extends Review of sBLA, Submitted by Novartis, for Ofatumumab in Relapsing Multiple Sclerosis

June 2, 2020 4:37 PM EDT

Media Release

Copenhagen, Denmark, June 2, 2020

The U.S. FDA has notified Novartis that the agency has extended its review of the sBLA for subcutaneous ofatumumab in RMSRegulatory action in the U.S. now anticipated in September 2020


Genmab A/S (Nasdaq: GMAB) announced today that the U.S. Food and Drug Administration (U.S. FDA) has notified Novartis that the agency has extended its review of the supplemental Biologics License Application (sBLA) for... More