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FDA warns Winder, GA-based Winder Laboratories about repeat CGMP violations in its manufacturing of finished drugs.[ Price : $8.95]
FDA accepts for priority review an Argenx supplemental BLA seeking to expand the use of its myasthenia gravis drug Vyvgart.[ Price : $8.95]
An Ars Technica post says FDA has dropped a Web page that listed some specific bogus autism treatments and therapies and warned of...[ Price : $8.95]
FDA warns Indias Chemspec Chemicals about CGMP deviations in its manufacturing of active pharmaceutical ingredients.[ Price : $8.95]
FDA warns Purushothaman Kumaran about failing to follow the investigational plan for a bioequivalence study at a hospital in Pondi...[ Price : $8.95]
FDA issues an untitled letter to BeOne Medicines USA, finding that its direct-to-consumer television advertisement for cancer drug...[ Price : $8.95]
The National Security Commission on Emerging Biotechnology recommends 22 policy actions in five key areas to modernize FDA medical...[ Price : $8.95]
FDA accepts for review a PharmaEssentia supplemental BLA seeking to expand the label of its interferon therapy Besremi to include ...