FDA warns Austell, GA-based Anatomy Supply Partners about multiple types of violations in its manufacturing of the Safe-T-Fill Micro Capillary Collect...
Taxpayers Protection Alliance executive director Ross Marchand says FDA needs to change its risk-averse approach to drug evaluation and accelerate app...
FDA warns Winder, GA-based Winder Laboratories about repeat CGMP violations in its manufacturing of finished drugs.
FDA accepts for priority review an Argenx supplemental BLA seeking to expand the use of its myasthenia gravis drug Vyvgart.
An Ars Technica post says FDA has dropped a Web page that listed some specific bogus autism treatments and therapies and warned of their potential hea...
Former FDA Oncology Center for Excellence director Richard Pazdur warns that political interference and internal upheaval are eroding the agencys abil...
FDA extends by three months its review of a Travere Therapeutics supplemental NDA for Filspari in focal segmental glomerulosclerosis.
The National Security Commission on Emerging Biotechnology recommends 22 policy actions in five key areas to modernize FDA medical biotechnology regul...
