Drug Approval | December 06, 2024
FDA accepts supplemental Biologics License Application for Roche’s Columvi combination
For people with relapsed or refractory diffuse large B-cell lymphoma
For people with relapsed or refractory diffuse large B-cell lymphoma
If approved, enfortumab vedotin with KEYTRUDA would be the first combination in China to offer an alternative to chemotherapy
The sBLA is supported by a usability study which confirmed that individuals over 18 years of age could self-administer
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
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
The updated COVID-19 vaccine is tailored to the KP.2 strain of the SARS-CoV-2 Omicron JN.1 lineage and is recommended for individuals 6 months of age and older
Susvimo is a unique therapeutic approach that provides continuous delivery of medicine to the eye through a refillable implant
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