Drug Approval | May 08, 2024
USFDA accepts Bristol Myers Squibb’s application for subcutaneous nivolumab
Subcutaneous nivolumab has potential to be the first and only subcutaneously administered PD-1 inhibitor
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
Submission based on positive results from global phase 3 study demonstrating overall survival benefit of TIVDAK over chemotherapy
If approved, Xolair would be the first medicine to reduce allergic reactions to multiple foods following an accidental exposure
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