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 ...
CDER and CBER launch the Rare Disease Evidence Principles process intended to bring greater speed and predictability to the review of rare disease the...
Memos posted on FDAs Web site from CBER director Vinay Prasad suggest the agency is raising the bar on future Covid-19 vaccination approvals.
FDA accepts for review an Achieve Life Sciences NDA for cytisinicline, an investigational treatment for helping those seeking to quit smoking.
Reuters reports that drug manufacturers are turning to artificial intelligence to reduce animal testing and cut costs and time in drug development.
