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 warns Clarksville, TN-based Insightra Medical about multiple violations in its production of intra-aortic balloon pump catheter kits with specific...
A new FDA clinical trial finds that cannabidiol may cause liver enzyme elevations in otherwise healthy adults raising new concerns about the safety o...
