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sBLA for Enhertu in High-Risk Early Breast Cancer

[ Price : $8.95]

FDA accepts for review a Daiichi Sankyo and AstraZeneca supplemental BLA for Enhertu use followed by paclitaxel, trastuzumab, and ...

FDA Approves Combo for Lung Cancer Maintenance

[ Price : $8.95]

FDA approves Jazz Pharmaceuticals Zepzelca (lurbinectedin) in combination with Genentechs Tecentriq or Tecentriq Hybreza for the m...

FDA Grants Fast Track for Alzheimers Drug

[ Price : $8.95]

FDA grants Bristol Myers Squibb fast-track status for its investigational Alzheimers therapy BMS-986446.

FDA Touts Sentinel Successes

[ Price : $8.95]

FDA issues a report highlighting Sentinel System activities and achievements between 2022 and 2024.

FDA, Vanda Agree on Dispute Actions

[ Price : $8.95]

FDA and Vanda agree to a series of actions to resolve their disputes over the companys Hetlioz and tradipitant.

CDRH Learn Module on Quality Management System

[ Price : $8.95]

A CDRH Learn module reviews the Quality Management System Regulation requirements for medical device manufacturers and the benefit...

17 New, 64 Revised Product-Specific Guidances

[ Price : $8.95]

FDA issues 17 new and 64 revised product-specific guidances to aid in developing generic drugs.

Umoja Bio Wins Fast Track for B-Cell Malignancies Drug

[ Price : $8.95]

FDA grants Umoja Biopharma a fast track designation for its investigational therapy UB-VV111 for treating relapsed or refractory l...

FDA Complete Response on Menkes Disease Drug

[ Price : $8.95]

FDA issues a complete response letter to Fortress Biotech and its majority-owned subsidiary, Cyprium Therapeutics, regarding their...

FDA Approves Novartis Rhapsido for Urticaria

[ Price : $8.95]

FDA approves a Novartis NDA for Rhapsido (remibrutinib), a Brutons tyrosine kinase inhibitor for treating adults with chronic spon...