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CGMP Violations at Exela Pharma Sciences

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FDA warns Lenoir, NC-based Exela Pharma Sciences about CGMP violations in its work as a drug manufacturing outsourcing facility.

Support for Biosimilar Legislation

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Forty health advocacy groups led by the Association for Accessible Medicines voice their support for legislation to eliminate the ...

FDA Prodded to Improve Surrogate Endpoint Transparency

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A Federation of American Scientists online paper says FDA, other federal research agencies, and Congress should take steps to incr...

Taiho Reports Unfavorable DMD Drug Data

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Taiho Pharmaceutical reports disappointing data from its Phase 3 extension study of TAS-205 (pizuglanstat) in patients with Duchen...

FDA Urged to Expand Real-World Data Use

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A bioethicists opinion piece in The Hill says FDA needs to expand its reliance on real-world clinical data to monitor the safety a...

Priority Review for Mercks Winrevair

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FDA accepts and will give priority review to a Merck sBLA for a Winrevair labeling update based on ZENITH trial results.

Vaccine Regulation Now a Political Process: Gottlieb

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Former FDA commissioner Scott Gottlieb raises significant questions about the current administrations handling of vaccines and vac...

Sandoz Recalls 1 Cefazolin Lot

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FDA says Sandoz has recalled one lot of Cefazolin for injection following a customer complaint that vials of another drug were inc...

FDA Clears Philips SmartSpeed Precise Software

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FDA clears Philips SmartSpeed Precise AI-enhanced software for MRI systems.

Myelodysplastic Syndrome Drug Development Guide

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FDA publishes a draft guidance to assist sponsors in developing drugs to treat myelodysplastic syndromes.