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FDA cites significant manufacturing and quality control concerns at a Celgene cell therapy facility in New Jersey, including defic...[ Price : $8.95]
FDA accepts for priority review a GSK NDA for its investigational hepatitis B treatment bepirovirsen.[ Price : $8.95]
Insulet recalls (Class 1) certain insulin pump components, warning that continued use could result in severe injury or death.[ Price : $8.95]
FDA releases the form FDA-483 with eight observations from an inspection at the Fujifilm Diosynth Biotechnologies Texas drug manuf...[ Price : $8.95]
FDA warns Franklin, TN-based Lexia LLC about CGMP violations in its production of over-the-counter drugs and cosmetic products[ Price : $8.95]
FDA warns Chinas Foshan Miwei Cosmetics Co. about CGMP violations in its production of three misbranded unapproved new over-the-co...[ Price : $8.95]
FDA warns Intas Pharmaceuticals Limited about CGMP violations in its production of finished drugs at the manufacturing facility in...[ Price : $8.95]
FDA accepts for priority review a Johnson & Johnson supplemental BLA for Imaavy (nipocalimab-aahu) as a potential treatment for wa...