FDA warns China’s 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, India.
FDA warns China’s 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, India.
FDA accepts for priority review a Johnson & Johnson supplemental BLA for Imaavy (nipocalimab-aahu) as a potential treatment for warm autoimmune hemolytic anemia.
FDA moves to increase pressure on Amgen to withdraw approval of autoimmune disease drug Tavneos (avacopan), concluding that the therapy lacks reliable evidence of effectiveness and raising serious concerns about data integrity in the original NDA submitted by the company’s subsidiary ChemoCentryx.
