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Abeona Plans BLA for Cell Therapy

[ Price : $8.95]

Abeona Therapeutics plans to file a BLA for EB-101, a cell therapy for patients with recessive dystrophic epidermolysis bullosa, a...

Breakthrough Designation for Quest Diagnostic

[ Price : $8.95]

FDA grants Quest Diagnostics a breakthrough device designation for its AAVrh74 ELISA assay for identifying Duchenne muscular dystr...

RAISE Program Explained

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Reagan-Udall Foundation director of research Carla Rodriguez explains the RAISE program that is helping to collect, curate, and in...

CGMP Violations at K.C. Pharmaceuticals

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FDA warns Pomona, CA-based K.C. Pharmaceuticals about CGMP violations in its production of finished drugs.

Gadal Laboratories CGMP Violations

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FDA warns Miami, FL-based Gadal Laboratories about CGMP violations in its production of finished drugs.

Tesla BioHealing Illegally Marketing Devices

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FDA warns Milford, DE-based Tesla BioHealing about illegally marketing adulterated and misbranded medical devices.

Janssen Seeks Full Approval for Balversa

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Janssen Pharmaceutical files a supplemental NDA that is seeking to convert Balversas (erdafitinib) 2019 accelerated approval to fu...

FDA OKs Expanded Indication for Reblozyl

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FDA approves a Bristol Myers Squibb BLA supplement for Reblozyl (luspatercept-aamt) for treating anemia in patients with very low-...

FDA Monitoring Social Media Drug Promotion: Post

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Two SheppardMullin attorneys say the second Warning Letter issued this year by the CDER Office of Prescription Drug Promotion show...

9 GA Congress Members Want Chemo Transparency

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A bipartisan group of nine members of Congress from Georgia calls for greater FDA transparency on efforts to resolve the current s...