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Enhertu granted Priority Review in the US for patients with metastatic HER2-positive solid tumours - Vimarsana News

Enhertu granted Priority Review in the US for patients with metastatic HER2-positive solid tumours

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 ...

Tarlatamab Application for SCLC Granted Priority Review by FDA - Vimarsana News

Tarlatamab Application for SCLC Granted Priority Review by FDA

The treatment developed by Amgen could be the first therapeutic option approved for third-line treatment of advanced small cell lung cancer (SCLC).

Source: ajmc.com
FDA Grants Priority Review to Amgen's Tarlatamab Application for Advanced Small Cell Lung Cancer - Vimarsana News

FDA Grants Priority Review to Amgen's Tarlatamab Application for Advanced Small Cell Lung Cancer

/PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the Company's...

European Commission Approves Pfizer's ELREXFIO® for Relapsed and Refractory Multiple Myeloma -December 08, 2023 at 07:56 am EST - Vimarsana News

European Commission Approves Pfizer's ELREXFIO® for Relapsed and Refractory Multiple Myeloma -December 08, 2023 at 07:56 am EST

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 ,...

European Commission Approves Pfizer's ELREXFIO for Relapsed and Refractory Multiple Myeloma - Vimarsana News

European Commission Approves Pfizer's ELREXFIO for Relapsed and Refractory Multiple Myeloma

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 ...