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Multiple Violations at Longhorn Vaccines and Diagnostics

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FDA warns Bethesda, MD-based Longhorn Vaccines and Diagnostics about Quality System, Medical Device Reporting, and Adulterated and...

FDA Asks for Rezolutes Ersodetug Data After Trial Miss

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FDA asks to look at Rezolutes Phase 3 data after the companys trial of ersodetug missed the primary endpoint, with the hope of cha...

FDA Open to Single Phase 3 for Netherton Syndrome Drug

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Quoin Pharmaceuticals says FDA has signaled openness to a streamlined development path for its rare disease candidate QRX003, indi...

Beam Eyes Accelerated Approval for Genetic Disease Therapy

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Beam Therapeutics says it will advance its base-editing therapy BEAM-302 into pivotal development to seek accelerated approval for...

4 Observations on Micro Labs 483

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FDA releases the form FDA-483 issued following an inspection at the Micro Labs drug manufacturing facility in Bengaluru, Karnataka...

Corcepts Lifyorli Combo in Platinum-Resistant Ovarian Cancer Approved

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FDA approves Corcept Therapeuticss cortisol-modulating drug Lifyorli (relacorilant) in combination with nab-paclitaxel for patient...

HELP Republican Senators Urge FDA Mifepristone Action

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Five Republicans on the Senate HELP Committee urge FDA to crack down on companies they say are illegally selling chemical abortion...

5 Key Points in New FDA Weight Loss Device Guidance

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Two Hogan Lovells attorneys highlight five areas in a new FDA final guidance on weight loss devices.

4 CGMP Issues in the Yangzhou Company Inspection

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FDA warns Chinas Yangzhou H&R Plastic Daily Chemical Company about CGMP violations in its production of finished drugs.

QS Violations at IsoTis OrthoBiologics

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FDA warns Irvine, CA-based IsoTis OrthoBiologics about Quality System violations in its production of Accell-branded resorbable ca...