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Medical Devices

Baxter Recalls Life2000 Ventilators

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

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Human Drugs

Monlunabant Trial Misses End Point in Kidney Trial

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

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Human Drugs

CGMP Violations in Imperial Palace Records

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

Biologics

BioStem Illegally Marketing Cellular Products: FDA

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

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Human Drugs

Global Calcium CGMP Deviations

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

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Biologics

Susvimo OKd for Diabetic Macular Edema

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

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Human Drugs

CGMP Issues in China University Contract Lab

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

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Medical Devices

Trokamed Sheath Instructions Update is Class 1: FDA

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

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Human Drugs

Supernus Wins OK for Parkinsons Drug

FDA approves a Supernus Pharmaceuticals NDA for Onapgo (apomorphine hydrochloride) injection for treating motor fluctuations in adults with advanced P...

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Medical Devices

Bard Pays $17 Million to Resolve Kickback Charges

The Justice Department says C.R. Bard and three affiliates have agreed to pay $17 million to resolve a whistleblowers allegations that the firm used i...