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
ILUMYA has already earned FDA approvals for scalp and nail plaque psoriasis in April 2024 and December 2025
Enhertu recently received Breakthrough Therapy Designation, accelerating development and review for this critical patient population
Zydus has in-licensed FYB206, a proposed biosimilar to immuno-oncology therapy Keytruda (pembrolizumab), exclusively from Formycon AG for the U.S. and Canadian markets
Arcellx develops innovative immunotherapies for cancer and other incurable diseases
If approved, DTX401 would be the first treatment to address the disease at its root cause
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