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Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that includes MSM Nutraceuticals, Cadila Healthcare and Swabplus.

Potential Dietary Supplement Statutory Changes

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FDA principal deputy commissioner Lloyd Schiller says the agency is looking at changes to the Dietary Supplement Health and Educat...

FDA Clinical Hold for Solid Biosciences Duchenne Trial

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FDA places a Solid Biosciences Phase 1/2 trial of its SGT-001 Duchenne muscular dystrophy drug on clinical hold.

F2G Gains Breakthrough for Olorofim in Mold Infections

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FDA grants F2G Ltd. a breakthrough therapy designation for olorofim for treating invasive mold infections in patients with limited...

FDA Rejects Lipocine NDA for Testosterone Drug

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FDA issues Lipocine a complete response letter on its NDA for Tlando, an oral testosterone product candidate for testosterone repl...

OTC Labeling Info Collection Extension

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Federal Register notice: FDA submits to OMB an information collection extension for Format and Content Requirements for Over-the-C...

Small Pharmacyֺs Role in Ranitidine Concerns

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Start-up pharmacy Valisure makes a name for itself by chemically validating drugs it purchases from wholesalers before fulfilling ...

Firm Sues FDA to Reverse Clinical Hold

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Regenxbio files a lawsuit in DC federal court against FDA, challenging a clinical hold on its gene therapy for retinal diseases.

Breakthrough for AI System for Endoscopy Images

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FDA grants AI Medical Service a Breakthrough Device Designation for its artificial intelligence programs that analyze endoscopy im...

Allergan Drug Gains Infectious Disease Designation

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FDA grants Allergan a Qualified Infectious Disease Product designation and fast track status for ATM-AVI (aztreonam and avibactam)...