FDA releases 89 previously unpublished complete response letters and says future letters will be released immediately after transmission to the sponso...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...
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.
