FDA Webview
X
about-us-banner

FDA Related News

Home / Articles / FDA Related News
Human Drugs

FDA Seizes Products Held Under Insanitary Conditions

On FDAs orders, U.S. marshals seize FDA-regulated products that the agency says were being held under insanitary conditions that exposed them to wides...

Human Drugs

Yupelri Approved for COPD Maintenance

FDA approves a Theravance Biopharma and Mylan NDA for Yupelri (revefenacin) inhalation solution for the maintenance treatment of patients with chronic...

FDA Illegally Regulates Some Devices as Drugs: Attorney

Attorney Jeffrey Shapiro says FDA should seek congressional authority to continue to regulate some medical devices as drugs.

Human Drugs

Vivozon Given Fast Track for Non-Opioid Pain Killer

FDA has granted Korea-based Vivozon a fast track designation for VVZ-149, a non-opioid pain killer.

Human Drugs

FDA Expanded Access Web Page Being Improved

FDA says it is updating its Expanded Access Web pages and taking other steps to improve the program for patients and healthcare providers.

Human Drugs

Cardiac Testing Still Needed for Diabetes Drugs: LaMattina

Former Pfizer executive John LaMattina says FDA should consider ways to streamline cardiovascular outcome trials for diabetes drugs to lower the cost ...

Medical Devices

New Monteris Medical NeuroBlate Probe Coming: FDA

FDA says it has cleared a new Monteris Medical probe to replace one that was recalled due to unintended overheating in the magnetic resonance environm...

Federal Register

Axiron Not Withdrawn Over Safety/Efficacy

Federal Register notice: FDA determines that Eli Lillys Axiron (testosterone) transdermal metered solution, 30 mg/1.5 ml actuation was not withdrawn f...

Human Drugs

Revive Therapeutics Orphan Status for Cannabidiol

FDA grants Revive Therapeutics an orphan drug designation for cannabidiol for preventing ischemia and reperfusion injury resulting from solid organ tr...

Federal Register

Pilot Survey to Assess Allergy to Cosmetics

Federal Register notice: FDA seeks comments on a new proposed information collection entitled Web-Based Pilot Survey To Assess Allergy to Cosmetics in...