FDA explains why it is proposing to refuse to approve a Vanda sNDA for a new indication for Hetlioz.
The Outsourcing Facilities Association and FDA reach a settlement agreement that compels the agency to promptly review long-pending nominations for ac...
Hyman, Phelps & McNamara attorneys and a medical device regulatory expert say an FDA final guidance on clinical decision support software will generat...
Reuters reports that FDA has again found quality issues at the Lilly Branchburg, NJ, drug manufacturing facility.
FDA accepts for priority review a Gilead Sciences supplemental BLA for Trodelv (sacituzumab govitecan-hziy) for treating certain adult patients with u...
FDA warns Mexicos Eksa Mills about CGMP violations in its manufacturing of finished drugs.
Federal Register: FDA revokes an emergency use authorization issued to Laboratorio Clinico Toledo, Puerto Rico, for its Laboratorio Clinico Toledo SAR...
Regeneron Pharmaceuticals and Sanofi say they will seek FDA approval next year for Dupixent (dupilumab) and its use in treating children with active e...
