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...

Biologics

Placebo-controlled Trials Needed for Vaccines: HHS

A self-described radical HHS policy now requires all new vaccines to be evaluated in placebo-controlled trials before theyre licensed for use, and thi...

Human Drugs

FDA Extends Aficamten Review Over REMS Request

FDA extends by three months its review of a Cytokinetics NDA for aficamten for treating patients with obstructive hypertrophic cardiomyopathy after re...

Human Drugs

Satsuma Migraine Resubmitted NDA Approved

FDA approves a Satsuma Pharmaceuticals 505(b)(2) NDA for Atzumi (dihydroergotamine (DHE)) nasal powder for the acute treatment of migraine.

Human Drugs

FDA OKs J&Js Imaavy for Myasthenia Gravis

FDA approves a Johnson & Johnson BLA for Imaavy (nipocalimab-aahu) for treating generalized myasthenia gravis.

FDA General

Unanimous SCOTUS Decision Reassuring: Post

George Washington University law professor Richard Pierce praises a recent unanimous Supreme Court decision backing FDA in an e-cigarette regulation c...

Human Drugs

Boehringer Drug Shows Encouraging Data in Lung Cancer

Boehringer Ingelheim releases new findings from its Beamion LUNG-1 trial, highlighting the potential of zongertinib as a breakthrough oral therapy for...