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
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
Approval is based on positive data from the Phase 3 ECHELON-3 trial
Recommendation based on results of Phase 3 CheckMate -9DW clinical trial demonstrating statistically significant and clinically meaningful improvement in overall survival with Opdivo plus Yervoy compared to investigator’s choice of lenvatinib or sorafenib in this patient population
For people with relapsed or refractory diffuse large B-cell lymphoma
Susvimo is a unique therapeutic approach that provides continuous delivery of medicine to the eye through a refillable implant
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