Alvogen asks the DC federal court to order FDA to grant final approval to its ANDA for generic buprenorphine film and affirm that Teva has forfeited m...
The BMJ reports that leaked documents from a cyberattack at the European Medicines Agency late last year revealed that regulators had major concerns o...
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...