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...
Johnson & Johnson says its gene therapy botaretigene sparoparvovec missed the primary endpoint in the Phase 3 LUMEOS study that is evaluating it for t...
A new report from IQVIA finds drug spending in 2024 accelerated, with net prices growing at an 11.4% rate last year compared with a 4.9% increase in 2...
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 ...
FDA says it is withdrawing two recent final guidances on cell- and tissue-based products and reissuing them in draft form to add changes based on undi...
