The FDA assigned a PDUFA target action date of December 22, 2026 –– The NDA is based on positive data from a successful clinical program ...
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Cogent Biosciences Touts Bezuclastinib Pivotal Wins, Eyes Up to Three FDA Filings and U.S. Launches
CEO Andrew Robbins outlined the company’s transition into a pre-commercial stage at an annual healthcare conference, ...
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and Medincell (Euronext: MEDCL), announced today that the U.S. Food and Drug Administration (FDA) ...
PARSIPPANY, N.J. & TEL AVIV, Israel & PARIS--(BUSINESS WIRE)-- Regulatory News: Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (TEVA), and Medincell (Euronext: MEDCL), ...
The FDA granted Priority Review to the BLA for Orca-T, an allogeneic stem cell and T-cell immunotherapy biologic for the treatment of hematological malignancies including acute myeloid leukemia, acute ...
After teasing a new regulatory process for personalized genetic medicines at the end of last year, the FDA today unveiled draft guidance for an approval pathway that could see custom CRISPR therapies, ...
The Tribune, now published from Chandigarh, started publication on February 2, 1881, in Lahore (now in Pakistan). It was started by Sardar Dyal Singh Majithia, a public-spirited philanthropist, and is ...
Alume Biosciences delivers positive topline results for three pivotal trials of Bevonescein, advancing toward NDA submission with US FDA in 2H 2026 Even with meticulous technique, surgeons are limited ...
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