FDA Related News

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...

Medical Devices

Lumitron Get Breakthrough Status for New X-Ray

FDA grants Lumitron Technologies a breakthrough device designation for its HyperVIEW X-Ray system for contrast-enhanced imaging for diagnosing breast ...

Human Drugs

RFK Jr.'s HHS Nomination Moves to Senate Floor

HHS secretary-nominee Robert F. Kennedy Jr.s nomination moves one step closer to completion after the Senate Finance Committee voted to advance it to ...

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.

Medical Devices

Gyder Hip System Cleared by FDA

FDA clears a Gyder Surgical 510(k) for the Gyder Hip System and its use in positioning the acetabular cup during hip replacement surgeries.

Medical Devices

Medtronic Recalls Cerebrospinal Fluid Drain Device

Medtronic Neurosurgery recalls certain Becker and Exacta External Drainage and Monitoring Systems due to a risk for cracks and leaks in device stopcoc...