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
The company showcased three core programs developed through this platform
CSIR-IGIB advances indigenous CRISPR Trials on sickle cell anaemia, anti-microbial resistance, liver fibrosis and rare disorders
Vevzuo is authorized for the prevention of skeletal related events in adults with advanced malignancies involving bone
ART-123 is a recombinant human thrombomodulin approved in Japan in 2008
InnoCell is the brand name for Mitsui Chemicals’ cell culture products and services
Durvalumab in combination with carboplatin and paclitaxel is indicated for the first-line treatment of adults with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy
Doxorubicin Hydrochloride Liposome Injection is indicated for the treatment of Ovarian Cancer, AIDS-Related Kaposi's Sarcoma, and Multiple Myeloma
Label updates reflect growing body of real-world evidence and regulatory confidence in the safety profile of the class of CD19- and BCMA-directed autologous CAR T cell therapies, reinforcing efforts to increase equitable access
The company's decision to withdraw the MAA was due to the timing of the availability of Chemistry Manufacturing and Controls
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