FDA Related News

Human Drugs

FDA Approves Jardiance for Heart Failure

FDA approves Boehringer Ingelheim and Eli Lillys diabetes drug Jardiance (empagliflozin) 10 mg for reducing the risk of cardiovascular death plus hosp...

Medical Devices

FDA Warning on All Eco-Med Ultrasound Gels

FDA issues a letter to healthcare providers warning them to stop using and discard all ultrasound gels and lotions manufactured by Eco-Med Pharmaceuti...

Medical Devices

Abiomeds Impella Heart Pump Gets Breakthrough

FDA grants a breakthrough designation to Abiomeds Impella ECP expandable percutaneous heart pump.

Human Drugs

Slight Drop in Number of Drug Manufacturing Sites: Report

The CDER State of Pharmaceutical Quality report for FY 2020 documents a slight decrease in the number of drug manufacturing sites and a slight decreas...

Human Drugs

FDA Signals NDA Path for Virpax Nasal Anti-viral Barrier

FDA tells Virpax Pharmaceuticals that it can proceed with additional research on MMS019, a high-density molecular masking spray under development for ...

Intended Use Final Rule Analyzed

Attorney Jeffrey Shapiro says the FDA final regulation on intended use is a modest improvement over past practice.

Medical Devices

FDA Says Purple Wristbands, Bracelets Only for DNR

FDA recommends hospitals standardize their use of purple medical device bracelets or wristbands to only signify Do Not Resuscitate status.

Human Drugs

Tempus PMA for xT-Onco Assay

Tempus files a PMA for its broad-panel DNA sequencing xT-Onco assay, an in vitro diagnostic device intended to assist healthcare professionals with da...

Biologics

Utah Cord Bank Hit with Warning Letter

A February FDA inspection at Utah Cord Bank (also known as Utah Cell Bank) determines that the firms cell products StemVive and StemMaxx are unapprove...

Medical Devices

Globus Medical Excelsius Imager Cleared

FDA has cleared a Globus Medical 510(k) for the Excelsius3D, an intraoperative three-in-one imaging system.