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
For patients with resectable early-stage gastric and gastroesophageal junction cancers
Based on the CRL, the STARGLO data do not provide sufficient evidence to support the proposed second-line DLBCL indication in the US patient population
Capricor’s BLA for Deramiocel received Priority Review in March 2025
Spikevax is now approved for all individuals aged 6 months through 64 years at increased risk for COVID-19 disease
Subcutaneous pembrolizumab administered every six weeks with a median injection time of two minutes, in combination with chemotherapy, shows consistent results across reported efficacy and safety endpoints compared to IV KEYTRUDA in combination with chemotherapy
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