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Genentech researchers say FDAs Drug Development Tools Qualification program has had a very limited impact on development programs....[ Price : $8.95]
Public health researchers warn about the broader impacts to emerging technologies (e.g., artificial intelligence) in a March court...[ Price : $8.95]
FDA sends ImmunityBio a refusal to file letter for its recent supplemental BLA submission seeking approval for Anktiva plus Bacill...[ Price : $8.95]
Capricor Therapeutics says it has completed an FDA mid-cycle review meeting on a BLA seeking approval for deramiocel and its use i...[ Price : $8.95]
FDA denies a CytoSorbents de novo marketing request for its DrugSorb-ATR antithrombotic removal system, intended for reducing the ...[ Price : $8.95]
FDA clears a GE HealthCare 510(k) for its MR Contour DL, an artificial intelligence model that uses deep learning for organs-at-ri...[ Price : $8.95]
FDA acccepts for review a Novo Nordisk NDA for a once-daily, 25 mg oral formulation of Wegovy (semaglutide) for chronic weight man...[ Price : $8.95]
FDA rehires some Freedom of Information office workers who were terminated under White House-mandated reduction-in-force cuts.