Acceptance based on results demonstrated a statistically significant improvement in overall survival versus chemotherapy alone in these patients
U.S. FDA has informed Moderna that due to administrative constraints, the agency will not complete its review of mRNA-1345 by the PDUFA date of May 12, 2024
Subcutaneous nivolumab has potential to be the first and only subcutaneously administered PD-1 inhibitor
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 based on results from pivotal phase III trial showing all primary endpoints met
Application based on results from the TROPION-Breast01 Phase III trial
The agreement licenses the company to launch in the United States, in February 2025, once approved by the U.S. FDA
Net product sales in the fourth quarter of 2023 include the recognition of $0.6 billion from deferred revenue, related to Gavi, the Vaccine Alliance
Submission to be reviewed under FDA real-time oncology review and Project Orbis
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