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
Vonvendi is the only recombinant Von Willebrand factor replacement therapy with approved indications in adults and children with VWD
The new subcutaneous autoinjector for lecanemab offers a self-administered, at-home treatment option for early-stage Alzheimer's disease
The updated formula for Spikevax is now approved for individuals 6 months through 64 years of age
VYVGART was well tolerated, with a safety profile consistent with prior studies in AChR-Ab seropositive gMG and other indications
Collaboration reinforces Boehringer Ingelheim’s expertise in microbial contract development and manufacturing
Subscribe To Our Newsletter & Stay Updated
