[ 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.[ Price : $8.95]
FDA says it is withdrawing two recent final guidances on cell- and tissue-based products and reissuing them in draft form to add c...[ Price : $8.95]
A citizen petition asks FDA to restrict the off-label use of the Da Vinci Robotic System and video-assisted thoracoscopy devices t...