If approved, the vaccine could help simplify the meningococcal vaccination schedule and provide the broadest serogroup coverage of any meningococcal vaccine
The CRL did not identify any outstanding scientific issues with the product.
On track to complete the BLA submission in the first half of 2022
Pfizer is evaluating the FDA’s comments and will work with the agency to determine an appropriate path forward
Trastuzumab is monoclonal antibody used to treat human epidermal growth factor receptor 2 positive (HER2+) breast cancer and metastatic gastric cancers
HYMPAVZI is already approved in the US for patients 12 and older with hemophilia A without factor VIII inhibitors or hemophilia B without factor IX inhibitors
The FDA’s regulatory decision is expected in Q2 2026 under the Prescription Drug User Fee Act (PDUFA)
A final decision on the updated application is expected in the first half of 2026, while intravenous (IV) Saphnelo remains commercially available
BioNTech is positioning 2026 as a defining year in its transition toward a multi-product oncology company
Diffuse large B-cell lymphoma (DLBCL), the most common type of non-Hodgkin lymphoma (NHL) in adults, represents 40% of all cases worldwide
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