FDA Related News

Medical Devices

Breakthrough Status for ACR-368 OncoSignature Assay

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

Medical Devices

Baxter Recalls Life2000 Ventilators

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

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.

Human Drugs

Global Calcium CGMP Deviations

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

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.

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 ...

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.

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...

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...

Feds Sued Over Removing Web Site Health Info

Represented by Public Citizen Litigation Group, Doctors for America sues FDA and several other agencies over their removal of Web pages and datasets n...