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
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
The resubmission of BLA for MOLBREEVI names Fujifilm as the drug substance manufacturer
The interim efficacy readout, involving around 170 participants with 15-month data, remains on track for the end of March 2026
INOVIO remains confident in the therapy’s benefits and intends to meet with the FDA to discuss maintaining eligibility under this pathway
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