FDA medical reviewers ask the Oncologic Drugs Advisory Committee to consider their concerns about the benefit-risk assessment of AstraZenecas breast c...
FDA cites significant manufacturing and quality control concerns at a Celgene cell therapy facility in New Jersey, including deficiencies in sterile p...
FDA accepts for priority review a GSK NDA for its investigational hepatitis B treatment bepirovirsen.
Insulet recalls (Class 1) certain insulin pump components, warning that continued use could result in severe injury or death.
FDA releases the form FDA-483 with eight observations from an inspection at the Fujifilm Diosynth Biotechnologies Texas drug manufacturing facility in...
FDA warns Franklin, TN-based Lexia LLC about CGMP violations in its production of over-the-counter drugs and cosmetic products
FDA warns Chinas Foshan Miwei Cosmetics Co. about CGMP violations in its production of three misbranded unapproved new over-the-counter drugs.
FDA warns Intas Pharmaceuticals Limited about CGMP violations in its production of finished drugs at the manufacturing facility in Selaqui, Dehradun, ...
