FDA commissioner Martin Makary reiterates that he wants to see clinical trials for new Covid vaccine boosters.
FDA clears a Teleflex 510(k) for an expanded indication for its QuikClot Control+ Hemostatic Device to include all grades of internal and external ble...
FDA warns Dr. Nana Barseghian about a bioresearch monitoring violation in a clinical trial at Northridge, CA-based Amicis Research Center.
The Trump administration asks a federal judge to dismiss a lawsuit filed by three GOP states that seeks to block access to the abortion pill mifeprist...
Genentech researchers say FDAs Drug Development Tools Qualification program has had a very limited impact on development programs.
Public health researchers warn about the broader impacts to emerging technologies (e.g., artificial intelligence) in a March court ruling that struck ...
FDA sends ImmunityBio a refusal to file letter for its recent supplemental BLA submission seeking approval for Anktiva plus Bacillus Calmette-Guerin f...
Capricor Therapeutics says it has completed an FDA mid-cycle review meeting on a BLA seeking approval for deramiocel and its use in treating Duchenne ...
