FDA Webview
X
about-us-banner

FDA Related News

Home / Articles / FDA Related News
EIRS/483s

Musks DOGE Cancels Leases on 30 FDA Field Offices

Elon Musks Department of Government Efficiency (DOGE) terminates the leases of 30 FDA field offices and laboratories throughout the U.S.

Medical Devices

FDA Clears Damae Medicals deepLive Skin Imager

FDA clears a Damae Medical 510(k) for its deepLive, an artificial intelligence-based imaging tool that provides real-time, three-dimensional visualiza...

Marketing

OPDP Hits Edenbridge Pharma Over Promos

CDER's Office of Prescription Drug Promotion sends an untitled letter to Edenbridge Pharmaceuticals over Hemady promotional materials used at a medica...

Human Drugs

Corcept Files NDA for Cushings Syndrome Drug

FDA accepts for review a Corcept Therapeutics NDA for relacorilant and its use in treating patients with endogenous hypercortisolism (Cushings syndrom...

FDA General

Rusfertide Phase 3 Data Meet Endpoints

Protagonist Therapeutics and Takeda report positive topline results for the Phase 3 VERIFY study that is evaluating rusfertide for treating polycythem...

Human Drugs

Lexicon Taps Pilavapadin 10mg for Phase 3

Lexicon Pharmaceuticals says it will advance pain drug pilavapadin 10mg into a planned Phase 3 trial based on just-announced Phase 2 PROGRESS study re...

EIRS/483s

PharmaTher Resubmits Ketamine NDA

PharmaTher also said it was working with its third-party manufacturing partner to resolve the deficiencies.

Medical Devices

Boston Scientific Recalls Pacemakers

Boston Scientific recalls its Accolade pacemakers and Visionist and Valitude cardiac resynchronization therapy pacemakers due to the possibility of th...

Medical Devices

Philips Recalls Tack Endovascular Device

Philips recalls its Tack Endovascular Systems due to customer complaints, including events where additional interventions were required to retrieve or...

Biologics

PhRMA Seeks Changes to Protocol Deviations Guide

Pharmaceutical Research and Manufacturers of America says FDA should make sure its recent draft guidance entitled Protocol Deviations for Clinical Inv...