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 denies a CytoSorbents de novo marketing request for its DrugSorb-ATR antithrombotic removal system, intended for reducing the severity of bleeding...
FDA clears a GE HealthCare 510(k) for its MR Contour DL, an artificial intelligence model that uses deep learning for organs-at-risk segmentation.
FDA acccepts for review a Novo Nordisk NDA for a once-daily, 25 mg oral formulation of Wegovy (semaglutide) for chronic weight management in certain o...
