Drug Approval | July 13, 2025
Moderna receives USFDA approval for Covid-19 vaccine ‘Spikevax’
Spikevax is now approved for all individuals aged 6 months through 64 years at increased risk for COVID-19 disease
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
TIVDAK is the first antibody-drug conjugate (ADC) to have positive overall survival data for patients with previously treated recurrent or metastatic cervical cancer
Sales reflect continued strong growth in oncology and vaccines
Submission to be reviewed under FDA real-time oncology review and Project Orbis
Submission based on positive results from global phase 3 study demonstrating overall survival benefit of TIVDAK over chemotherapy
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