TherapeuticsMD asks FDA to impose restrictions on any marketing application for a generic form of its Annovera birth control product.
Federal Register notice: FDA sends to OMB an information collection entitled Empirical Study of Promotional Implications of Proprietary Prescription D...
Federal Register notice: FDA announces a 4/27-29 Oncologic Drugs Advisory Committee meeting to hear updates on certain supplemental BLAs that were gra...
Federal Register notice: FDA seeks comments on an information collection extension entitled Request for Samples and Protocols.
Sanofi and Regeneron stop a Phase 3 clinical trial on PD-1 inhibitor Libtayo (cemiplimab) based on positive data and now plan an FDA submission later ...
FDA issues a safety alert on Strykers Scandinavian Total Ankle Replacement device due to a higher than expected risk of the devices polyethylene compo...
FDA issues PharmaEssentia a complete response letter on its BLA for ropeginterferon alfa-2b-njft for treating polycythemia vera, requesting additional...
FDA lifts a clinical hold against a Histogen IND application package for a planned Phase 1/2 clinical trial of its HST-003, which intended to evaluate...