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Multiple Violations in Foshan Miwei Cosmetics Inspection

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FDA warns Chinas Foshan Miwei Cosmetics Co. about CGMP violations in its production of three misbranded unapproved new over-the-co...

CGMP Issues at Intas Dehradun Unit

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FDA warns Intas Pharmaceuticals Limited about CGMP violations in its production of finished drugs at the manufacturing facility in...

J&J Imaavy sBLA for Rare Anemia Gets Priority Review

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FDA accepts for priority review a Johnson & Johnson supplemental BLA for Imaavy (nipocalimab-aahu) as a potential treatment for wa...

Tavneos Withdrawal Sought Over Data Manipulation, Safety Risks

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FDA moves to increase pressure on Amgen to withdraw approval of autoimmune disease drug Tavneos (avacopan), concluding that the th...

FDA Evaluating Measures to Modernize Clinical Trials

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FDA seeks to modernize how clinical trials are conducted, unveiling a pair of proof-of-concept studies and outlining plans for a b...

FDAs Early QMSR Priorities Seen

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A Quality Magazine article explains what FDA investigators have focused on in their initial Quality Management System Regulation i...

5 Observations on Excelvision FDA-483

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FDA releases the form FDA-483 issued after a 2024 inspection at the Excelvision drug manufacturing facility in Annonay, Ardche, Fr...

Fast Track for Scancell iSCB1+ in Advanced Melanoma

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FDA grants a fast track designation to Scancells advanced melanoma investigational drug iSCB1+.

FDA Still Weighing Potential CBER Director Candidates

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FDA commissioner Marty Makary says the agency is still weighing candidates to lead CBER as controversial director Vinay Prasad pre...

Rocket Pharma Sells Priority Voucher for $180 Million

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Rocket Pharmaceuticals sells an FDA rare pediatric disease priority review voucher for $180 million to support its gene therapy pi...