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, ...
FDA accepts for priority review a Johnson & Johnson supplemental BLA for Imaavy (nipocalimab-aahu) as a potential treatment for warm autoimmune hemoly...
FDA moves to increase pressure on Amgen to withdraw approval of autoimmune disease drug Tavneos (avacopan), concluding that the therapy lacks reliable...
