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 accepts and will give priority review to a Merck sBLA for a Winrevair labeling update based on ZENITH trial results.
Former FDA commissioner Scott Gottlieb raises significant questions about the current administrations handling of vaccines and vaccine innovation in w...
