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February 19, 2024
Patients in the US with epidermal growth factor receptor mutated (EGFRm) advanced lung cancer can now receive an important new treatment option delaying disease progression by nearly nine additional months.
February 2, 2024
SHANGHAI, China, Feb. 01, 2024 -- Shanghai Junshi Biosciences Co., Ltd , a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of...
February 2, 2024
SHANGHAI, China, Feb. 01, 2024 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences”, HKEX: 1877; SSE: 688180), a leading...
January 30, 2024
In a groundbreaking development, on Jan. 8, 2024, the U.S. Food and Drug Administration (FDA) announced a pilot program called Collaboration on Gene Therapies Global Pilot to ensure its leadership in the regulation of cell and gene therapy, and to secure the U.S. market as the most prominent place for development of novel therapies.
January 29, 2024
Application based on results from DESTINY-PanTumor02 trial and supported by additional ENHERTU data Submission to be reviewed under FDA Real Time Oncology Review and Project Orbis If approved,...
January 29, 2024
AstraZeneca and Daiichi Sankyo's supplemental Biologics License Application (sBLA) for Enhertu (trastuzumab deruxtecan) has been accepted and granted Priority Review in the US for the treatment of adult patients with unresectable or metastatic HER2-positive (immunohistochemistry [IHC] 3+) solid tumours who have ...
December 14, 2023
The treatment developed by Amgen could be the first therapeutic option approved for third-line treatment of advanced small cell lung cancer (SCLC).
December 13, 2023
/PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the Companys...
December 8, 2023
Conditional marketing authorization is based on clinically meaningful response rates, duration of response, and safety from the Phase 2 MagnetisMM-3 trial ELREXFIO is an off-the-shelf ,...
December 8, 2023
08.12.2023 - Pfizer Inc. (NYSE:PFE) today announced the European Commission (EC) has granted conditional marketing authorization for ELREXFIO (elranatamab). ELREFXIO is a targeted immunotherapy for the treatment of adult patients with relapsed and refractory ...