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FDA posts a four-item Form FDA 483 that was issued to Laboratorios Grifols after a 7/2024 inspection of the firms drug manufacturi...[ Price : $8.95]
FDA accepts for review a Daiichi Sankyo and AstraZeneca supplemental BLA for Enhertu use followed by paclitaxel, trastuzumab, and ...[ Price : $8.95]
FDA approves Jazz Pharmaceuticals Zepzelca (lurbinectedin) in combination with Genentechs Tecentriq or Tecentriq Hybreza for the m...[ Price : $8.95]
FDA grants Bristol Myers Squibb fast-track status for its investigational Alzheimers therapy BMS-986446.[ Price : $8.95]
FDA issues a report highlighting Sentinel System activities and achievements between 2022 and 2024.[ Price : $8.95]
FDA and Vanda agree to a series of actions to resolve their disputes over the companys Hetlioz and tradipitant.[ Price : $8.95]
A CDRH Learn module reviews the Quality Management System Regulation requirements for medical device manufacturers and the benefit...[ Price : $8.95]
FDA issues 17 new and 64 revised product-specific guidances to aid in developing generic drugs.