FDA says an advisory committee is not needed to discuss the Aquestive NDA for Anaphylm to treat severe allergic reactions.
FDA releases 89 previously unpublished complete response letters and says future letters will be released immediately after transmission to the sponso...
Medtronic Perfusion Systems recalls (Class 1) its DLP Left Heart Vent Catheters (malleable body and vented connector) because the devices may not reta...
FDA posts a drug complex innovative design case study for a higher dose of an alopecia areata drug that did not assign participants to a separate plac...
FDA warns Amneal Pharmaceuticals about CGMP violations in its Gujarat, India, drug manufacturing facility.
Over a thousand current and former staff at FDA, CDC, and NIH pen a new open letter to HHS secretary Robert F. Kennedy Jr. and Congress, calling for K...
The Guardian says CBER director Vinay Prasad successfully had videos of him criticizing Covid vaccines removed from the YouTube channel of a physician...
FDA grants Boehringer Ingelheim a breakthrough therapy designation for Hernexeos (zongertinib) tablets for the first-line treatment of certain adults ...