FDA Related News

Medical Devices

FDA Approves Element Science Wearable Defibrillator

FDA approves the Element Science PMA for its Jewel Patch wearable cardioverter defibrillator.

Medical Devices

Edwards Expands SAPIEN for Asymptomatic Patients

FDA approves Edwards Lifesciences' SAPIEN 3 transcatheter aortic valve replacement platform for patients with severe aortic stenosis who show no sympt...

Human Drugs

Semaglutide Wins in Steatohepatitis, Fibrosis

A Phase 3 trial funded by Novo Nordisk showed that its Ozempic/Wegovy outperformed placebo in patients with steatohepatitis and fibrosis.

Drug Safety Monitoring Hurt by FDA Staff Cuts: Post

Chemistry & Engineering News reports that reductions in CDER Division of Drug Information staff are affecting FDAs ability to maintain databases and r...

Human Drugs

Reopen FDA San Juan Lab: Representatives

Reps. Alexandria Orcasio-Cortez and Nydia Velzquez ask HHS secretary Robert F. Kennedy, Jr., to reopen the FDA San Juan medical products laboratory th...

Human Drugs

Immunic Reports Positive Data on MS Drug

Immunic reports positive data from its Phase 2 CALLIPER trial of nuclear receptor related 1 activator vidofludimus calcium (IMU-838) in patients with ...

Human Drugs

Gilead Pays $202 Million Over Kickbacks Scheme

Gilead Sciences agrees to pay $202 million to resolve claims that the company offered and paid kickbacks (e.g., honoraria payments, meals, and travel ...

Biologics

Makary Suggests Raising Bar on Covid Boosters

FDA commissioner Marty Makary suggests more data could be required for Covid-19 vaccine boosters this winter.

FDA General

Little Trust in New Health Leaders: Poll

A poll from the Harvard University T.H. Chan School of Public Health finds that more Americans say they will be trusting public health agencies less i...

FDA General

FDA Layoffs Affect Product Development: Post

Skadden attorneys say the FDA reduction in force should have the greatest negative impact on products that are in development.