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...
FDA says Sandoz has recalled one lot of Cefazolin for injection following a customer complaint that vials of another drug were included in a Cefazolin...
