FDA Webview
X
about-us-banner

FDA Related News

Home / Articles / FDA Related News
latest-news-card-1
Human Drugs

CGMP Deviations at Wuhu Nuowei Chemistry

FDA warns Chinas Wuhu Chemistry about CGMP deviations in its manufacturing of active pharmaceutical ingredients.

latest-news-card-1
Medical Devices

Olympus Recalls Bronchoscope Guide Sheaths

Olympus recalls its bronchoscope single-use guide sheath kits due to potential for the radiopaque tip of the sheath component to separate and fall off...

latest-news-card-1
Human Drugs

AnaptysBio Reports Positive Data on Arthritis Drug

AnaptysBio reports positive data from a Phase 2 study of rosnilimab for treating moderate-to-severe rheumatoid arthritis.

latest-news-card-1
Medical Devices

Max Mobility Recalls Wheelchair Speed Control Dial

Max Mobility recalls its Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial for wheelchair use due to a faulty circuit board in its speed contro...

latest-news-card-1
Human Drugs

Strukmyer Medical CGMP Violations

FDA warns Mesquite, TX-based Strukmyer Medical about CGMP violations in manufacturing finished drugs and cosmetics.

latest-news-card-1
Human Drugs

Chengdu Records Review Finds CGMP Deviations

FDA warns Chinas Chengdu Innovation Pharmaceutical Co. about CGMP deviations in manufacturing active pharmaceutical ingredients.

latest-news-card-1

Court Orders FDA to Restore Gender Web Pages

DC federal judge John Bates orders FDA and CDC to re-post Web pages and datasets they removed to comply with President Trumps executive order on gende...

latest-news-card-1
Human Drugs

Change FDA Approach to Antibiotic Approval: Column

A STAT First Opinion column calls on FDA to focus on how effective new antibiotics are in real-world patients, rather than approving them based on how...

latest-news-card-1
Human Drugs

Biohaven NDA Filed for Spinocerebellar Ataxia Drug

FDA accepts for priority review a Biohaven NDA for troriluzole for treating adult patients with spinocerebellar ataxia.

latest-news-card-1
Medical Devices

Breakthrough Status for Knee Arthritis Device

FDA grants Guerbet a Breakthrough Device Designation for LipioJoint, a liquid embolic agent designed to alleviate pain in patients with knee osteoarth...