FDA publishes the first in a series of guidances with standards for medical device submissions in electronic format.
House Energy and Commerce chair Frank Pallone (D-NJ) says the current youth vaping epidemic could have been averted if FDA in 2017 had not delayed rev...
FDA grants breakthrough therapy designation to Achillion Pharmaceuticals danicopan for treating paroxysmal nocturnal hemoglobinuria.
FDA approves Abiomeds newest heart pump, the Impella 5.5 with SmartAssist, indicated for temporary ventricular support (14 days) and for treating ongo...
FDA grants Aurora Concussion Therapy Systems a breakthrough device designation for its Aurora Light Therapy System for treating concussions.
Florida submits a concept paper to HHS explaining how it wants to operate a Canadian prescription drug importation program.
The White House says President Trump has signed an executive order intended to modernize flu vaccines and help protect more Americans through vaccinat...
FDA updates its preliminary list of approved NDAs that will be considered BLAs as of 3/23/20.