Federal Register notice: FDA announces a 4/13 Antimicrobial Drugs Advisory Committee meeting on developing antibacterial drugs that treat a single spe...
FDA approves two Gilead Sciences supplemental NDAs for Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) to treat hepatitis C virus in chil...
GlaxoSmithKline recalls 593,000 Ventolin HFA (albuterol sulfate) inhalation aerosol, 90 mcg per actuation (200 metered doses) due to a manufacturing d...
Three researchers say that between 2011 and 2015, FDA approved new drugs more quickly than the European Medicines Agency.
Emergo reports that FDA 510(k) clearances were at a four-year low in 2016, as the number of applications from U.S. firms declined.
FDA commissioner-nominee Scott Gottlieb says his highest immediate priority will be to assess whether the agency has adequate authorities and resource...
FDA clears a Bausch + Lomb 510(k) for the Stellaris Elite Vision Enhancement System, the companys next generation phacoemulsification cataract platfor...
A Wall Street Journal opinion piece dismisses Democrat lawmakers criticisms of FDA commissioner-nominee Scott Gottliebs close ties to industry, and ca...