A letter from dozens of biotechnology industry executives and investors urges FDA commissioner Marty Makary to reject efforts to restrict access to th...
FDA drops REMS requirements covering embryofetal toxicity risk in endothelin receptor antagonists.
FDA warns Lenoir, NC-based Exela Pharma Sciences about CGMP violations in its work as a drug manufacturing outsourcing facility.
Forty health advocacy groups led by the Association for Accessible Medicines voice their support for legislation to eliminate the distinction between ...
A Federation of American Scientists online paper says FDA, other federal research agencies, and Congress should take steps to increase surrogate endpo...
Taiho Pharmaceutical reports disappointing data from its Phase 3 extension study of TAS-205 (pizuglanstat) in patients with Duchenne muscular dystroph...
A bioethicists opinion piece in The Hill says FDA needs to expand its reliance on real-world clinical data to monitor the safety and effectiveness of ...
FDA issues a complete response letter to Unicycive Therapeutics for its hyperphosphatemia drug oxylanthanum carbonate that cites issues with a manufac...
