Drug Approval | March 01, 2024
Biocon Biologics secures US market entry date for Bmab 1200
The agreement licenses the company to launch in the United States, in February 2025, once approved by the U.S. FDA
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
If approved, patritumab deruxtecan would be a first-in-class HER3 directed DXd antibody drug conjugate for these patients
Submissions based on positive data from the Phase 3 BASIS trial, which were presented this past weekend at the American Society of Hematology (ASH) Annual Meeting
Merck to pay Daiichi Sankyo a $4 billion upfront payment in addition to $1.5 billion in continuation payments over the next 24 months
The company had submitted a comprehensive Corrective and Preventive Action (CAPA) plan in September 2022
BioNTech's diverse pipeline includes multiple drugs in Phase I, II, and III clinical trials
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