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Calliditas Therapeutics has announced that the U.S. Food and Drug Administration has extended the PDUFA goal date for its New Drug Application (NDA) seeking accelerated approval for Nefecon to December 15, 2021. In March 2021 Calliditas filed for FDA approval using the Accelerated Approval PrograAlready a subscriber Login You have…
The company will consolidate its manufacturing activities in Kvistgaard, Denmark with the aim of optimizing productivity and profitability. As part of this consolidation, the company will prepare the Kvistgaard facility for the future commercial production of its prostate cancer vaccine, PROSTVACAlready a subscriber Login You have read all your free…
InDex Pharmaceuticals Holding has received positive responses from FDA and EMA regarding its phase III development of the TLR9 agonist cobitolimod, for the treatment of moderate to severe ulcerative colitis. Following the phase IIb study CONDUCT meeting its primary endpoint in August 2019, dialogAlready a subscriber Login You have read…
The FDA has accepted for priority review the Biologics License Application for efanesoctocog alfa for the treatment of hemophilia A. Sanofi and Sobi collaborate on the development and commercialization of efanesoctocog alfa. “Factor therapy remains a cornerstone of hemophilia treatment, but Already a subscriber Login You have read all your…
