FDA Related News

Human Drugs

Pfizer Gets Expanded Approval for Adcentris

FDA approves a Pfizer supplemental BLA for Adcetris (brentuximab vedotin) in combination with lenalidomide and rituximab for treating certain adult pa...

Human Drugs

Bioresearch Monitoring Issue at ISOThrive

FDA warns Healdsburg, CA-based ISOThrive about failing to submit an IND for two clinical trials it sponsored of an investigational drug.

Human Drugs

CGMP Deviations at Wuhu Nuowei Chemistry

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

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...

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.

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...

Human Drugs

Strukmyer Medical CGMP Violations

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

Human Drugs

Chengdu Records Review Finds CGMP Deviations

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

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...

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...