FDA accepts for review a Daiichi Sankyo and AstraZeneca supplemental BLA for Enhertu use followed by paclitaxel, trastuzumab, and pertuzumab as a neoa...
FDA approves Jazz Pharmaceuticals Zepzelca (lurbinectedin) in combination with Genentechs Tecentriq or Tecentriq Hybreza for the maintenance treatment...
FDA commissioner Martin Makary says on a CNN podcast that changes should soon be announced to a Boxed Warning on some hormone replacement therapy prod...
FDA grants Bristol Myers Squibb fast-track status for its investigational Alzheimers therapy BMS-986446.
FDA issues a report highlighting Sentinel System activities and achievements between 2022 and 2024.
FDA and Vanda agree to a series of actions to resolve their disputes over the companys Hetlioz and tradipitant.
A CDRH Learn module reviews the Quality Management System Regulation requirements for medical device manufacturers and the benefits that flow from fol...
FDA issues 17 new and 64 revised product-specific guidances to aid in developing generic drugs.
