Vonvendi is the only recombinant Von Willebrand factor replacement therapy with approved indications in adults and children with VWD
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
Submission based on positive results from global phase 3 study demonstrating overall survival benefit of TIVDAK over chemotherapy
This sBLA submission is supported by clinical, pre-clinical, and manufacturing data demonstrating the safety, tolerability, and immunogenicity of the bivalent vaccine.
This combination has the potential to be the first treatment option combining an antibody-drug conjugate plus an immunotherapy in this treatment setting
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
The submission is supported by results from the Phase 3b APEX study
For patients with resectable early-stage gastric and gastroesophageal junction cancers
Spikevax is now approved for all individuals aged 6 months through 64 years at increased risk for COVID-19 disease
Subscribe To Our Newsletter & Stay Updated
