CytoDyn files clinical and chemistry, manufacturing and controls portions of a BLA for leronlimab as a combination therapy in HIV patients.
Federal Register notice: FDA announces it is contemplating a grant of an exclusive patent license to Sciogen for two patents on influenza virus recomb...
FDA grants a Bayer request for a variance from some medical device reporting requirements regarding its controversial Essure contraceptive.
Federal Register notice: FDA reopens for 60 days the comment period for a 1/3 Federal Register notice seeking input from interested stakeholders on th...
Janssen submits two supplemental BLAs for Simponi Aria (golimumab) for treating polyarticular juvenile idiopathic arthritis and juvenile psoriatic art...
FDA asks a federal court to lift portions of a consent decree affecting Royal Philips to allow the company to resume manufacturing and shipping extern...
FDA posts a new guidance entitled Enforcement Policy for Remote Digital Pathology Devices During the Coronavirus Disease 2019 (Covid-19) Public Health...