Biotech | July 08, 2025
Duke Street Bio receives FDA fast track designation for PARP1-selective inhibitor with CNS activity
Addresses brain metastases harboring BRCA1/2 and/or HRR alterations—an area of high unmet need
Addresses brain metastases harboring BRCA1/2 and/or HRR alterations—an area of high unmet need
Approval based on NIAGARA Phase III trial results which showed a 32% reduction in the risk of recurrence and a 25% reduction in the risk of death for the Imfinzi regimen vs. neoadjuvant chemotherapy alone
The acquisition of Pivya is an important step in Alembic’s ability to provide branded pharmaceutical product to the US Healthcare market
TEVIMBRA is a uniquely designed anti-PD-1 monoclonal antibody developed by BeiGene (now BeOne Medicines)
First and only TROP2-directed therapy approved in the US for the treatment of lung cancer
The program will start with providing bTrastuzumab to cancer patients facing treatment delays due to budget constraints
Innovative agents highlight growth of targeted protein degradation platform and BMS' leadership in innovative cancer therapies
Globally, BRUKINSA is approved in more than 70 countries
46% reduction in the risk of disease progression or death, and 27% reduction in the risk of death, in an aggressive cancer type with limited survival and few treatment options
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