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Breakthrough Status for ACR-368 OncoSignature Assay

[ Price : $8.95]

FDA grants Acrivon Therapeutics a breakthrough device designation for the ACR-368 OncoSignature assay, a multiplex immunofluoresce...

Baxter Recalls Life2000 Ventilators

[ Price : $8.95]

Baxter Healthcare Corporation recalls its Life2000 Ventilator System due to a nonconforming battery charger.

Monlunabant Trial Misses End Point in Kidney Trial

[ Price : $8.95]

Novo Nordisk says a recent Phase 2 trial of monlunabant in diabetic kidney disease patients failed to meet its primary endpoint.

CGMP Violations in Imperial Palace Records

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FDA warns Chinas Imperial Palace Commodity about CGMP violations in its manufacturing of over-the-counter drugs.

BioStem Illegally Marketing Cellular Products: FDA

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FDA warns Pompano Beach, FL-based BioStem Life Sciences that it is illegally marketing cellular products that also reflect CGMP vi...

Global Calcium CGMP Deviations

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FDA warns Indias Global Calcium about CGMP deviations in its manufacture of active pharmaceutical ingredients.

Susvimo OKd for Diabetic Macular Edema

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FDA approves a Genentech supplemental BLA for Susvimo (ranibizumab injection) 100 mg/mL for treating diabetic macular edema.

CGMP Issues in China University Contract Lab

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FDA warns Chinas Center for Instrumental Analysis of China Pharmaceutical University about CGMP deviations in its work as a contra...

Trokamed Sheath Instructions Update is Class 1: FDA

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FDA says a Trokamed recall updating instructions for its Mini PCNL sheath was Class 1.

Supernus Wins OK for Parkinsons Drug

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FDA approves a Supernus Pharmaceuticals NDA for Onapgo (apomorphine hydrochloride) injection for treating motor fluctuations in ad...