Application being reviewed under the FDA Project Orbis framework, which enables concurrent reviews among US, Australia, Canada, Switzerland, Singapore and United Kingdom health authorities
Dr. Adams brings more than two decades of experience leading the manufacturing of biologic and gene therapies at all stages of development.
This sBLA submission is supported by clinical, pre-clinical, and manufacturing data demonstrating the safety, tolerability, and immunogenicity of the bivalent vaccine.
Submissions based on favorable MagnetisMM-3 trial results in patients with relapsed or refractory multiple myeloma
Clinical studies are expected to start in Q2 2023.
This action follows the recent acceptance of the Marketing Authorization Application (MAA) for Pfizer’s RSV vaccine candidate by the European Medicines Agency
Olaparib is indicated primarily for certain forms of ovarian, breast, pancreatic, and prostate cancer
Upon approval, XPHOZAH would be the first and only phosphate absorption inhibitor, offering patients a novel mechanism
If approved, the vaccine could help simplify the meningococcal vaccination schedule and provide the broadest serogroup coverage of any meningococcal vaccine
Her previous role at Novartis, where she was general manager, data & digital, in global drug development, also included accountability for driving the DCT strategy, programs and platforms
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