FDA Related News

Medical Devices

FDA Clears Ezra Flash AI

FDA clears an Ezra 510(k) for its Ezra Flash AI model for MRI imaging.

Medical Devices

PolarityBio Gets Breakthrough Status for SkinTE

FDA grants PolarityBio a breakthrough therapy designation for SkinTE for treating Wagner Grade 1 diabetic foot ulcers.

Marketing

Bipartisan Bill on Influencer, Telehealth Ads

Sens. Durbin and Marshall introduce the Protecting Patients from Deceptive Drug Ads bill to increase and improve FDA oversight of drug ads featuring s...

Human Drugs

Report Finds Troubling Drug Imports for Weight Loss

Partnership for Safe Medicines releases a new report finding suspicious, unauthorized, and illegal ingredients for popular diabetes and obesity inject...

Human Drugs

FDA Refusal to File Wakix sNDA

FDA refuses to file a Harmony Biosciences Wakix sNDA to treat excessive daytime sleepiness due to idiopathic hypersomnia.

Human Drugs

AGs Seek FDA Actions on Counterfeit GLP-1 Drugs

A bipartisan coalition of 37 state Attorneys General call on FDA to take enforcement actions against online sellers of counterfeit versions of popular...

Human Drugs

Disappointing Data on Supernus Depression Drug

Supernus Pharmaceuticals says its Phase 2b study of SPN-820 in adults with treatment-resistant depression did not demonstrate a statistically signific...

Human Drugs

Expanded Access to TICE BCG Substitute

FDA approves an ImmunityBIO expanded access program for recombinant BCG to help address a BCG shortage in treating bladder cancer.

What Happens to FDA in a Budget Shutdown?

Hyman, Phelps & McNamara regulatory and medical device principal expert Richard Lewis uses his experience at FDA during the 2018-2019 government shutd...

FDA General

AdvaMed Urges HHS Reversal of FDA Staff Cuts

Advamed president Scott Whitaker writes HHS to urge a reversal of staff cuts at CDRH to avoid a negative impact on patient care.