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
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
Acceptance based on results demonstrated a statistically significant improvement in overall survival versus chemotherapy alone in these patients
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