FDA Related News

Human Drugs

Merck Touts Welireg in Kidney Cancer

Merck says it will submit to FDA favorable data from its LITESPARK-005 Phase 3 trial evaluating Welireg (belzutifan) for treating certain adults with ...

Medical Devices

FDA Updates Warning on UV Wands

FDA updates its list of ultraviolet wand products that may present a potential risk of injury.

Medical Devices

GE Mobile Patient Monitor Cleared

FDA clears a GE HealthCare 510(k) for its Portrait Mobile wireless and wearable monitoring device.

Human Drugs

FDA Oks Ipsens Sohonos for FOP

FDA approves Ipsens Sohonos as the first treatment for adults and some pediatric patients with fibrodysplasia ossificans progressiva.

Medical Devices

Cardiosave Balloon Pump Recall Class 1: FDA

FDA says the Datascope/Maquet/Getinge recall of Cardiosave balloon pumps is Class 1.

Medical Devices

BlueWind De Novo for Incontinence Device

FDA grants BlueWind Medical a de novo marketing authorization request for the Revi System, a tibial neuromodulation therapy for treating the symptoms ...

Federal Register

Workshop on Postapproval Pregnancy Studies

Federal Register notice: FDA announces a 9/18-19 public workshop entitled Optimizing the Use of Postapproval Pregnancy Safety Studies.

Human Drugs

Vanda Pushes Back on Hetlioz sNDA Hearing Denial

A sharply-worded Vanda response to FDA says commissioner Robert Califf should reject a CDER proposed order and either approve Vandas sNDA for a Hetlio...

Medical Device, Drug Recalls Drop in Q2: Sedgwick

The Segwick Recall Index shows that both medical device and drug recalls dropped in the second quarter of 2023 from the first quarter.

Human Drugs

Orphan Status for Biliary Tract Cancer Drug

FDA grants Nuvectis Pharmas NXP800 an orphan drug designation for treating biliary tract cancer.