FDA Webview
X
about-us-banner

FDA Related News

Home / Articles / FDA Related News
Medical Devices

FDA Reminds Surgical Staffs About Fire Risk

FDA reminds healthcare professionals working in surgical settings of the risk of surgical fires that can injure patients.

Human Drugs

cIAI Drug Development Guidance

FDA issues a guidance to assist in developing drugs to treat complicated intra-abdominal infections.

FDA General

Latest Federal Register Notices

FDA Review posts the Federal Register notices for the week ending 5/25/2018.

Human Drugs

Product Approval Summaries

FDA Review posts product approval summaries for the week ending 5/25/2018.

Human Drugs

BioMarin Rare Disease Drug Approved

FDA approves a BioMarin Pharmaceutical NDA for Palynziq (pegvaliase-pqpz) for adults with phenylketonuria, a rare and serious genetic disease.

Medical Devices

XableCath 510(k) Cleared for Abrasion Tip Support Catheter

FDA clears a XableCath 510(k) for its XableCath abrasion tip support catheter for use by interventionalists in managing lesions and procedures in the ...

Medical Devices

Imagen De Novo OK for AI Software Fracture Finder

FDA grants Imagen a de novo marketing authorization for its OsteoDetect device, a computer-aided detection and diagnosis software designed to detect w...

Human Drugs

Fast Track for Krystal Biotech Topical Drug

FDA grants Krystal Biotech a fast track designation for KB103 for treating dystrophic epidermolysis bullosa.

Human Drugs

Pfizer Gains Breakthrough Status for Rare Disease Drug

FDA grants Pfizer a breakthrough therapy designation for tafamidis for treating patients with transthyretin cardiomyopathy, a rare and fatal condition...

Human Drugs

Acel Rx Resubmits NDA for Pain Drug

FDA accepts for review an AcelRx Pharmaceuticals NDA resubmission for Dsuvia (sufentanil sublingual tablet, 30 micrograms) for treating moderate-to-se...