News about "US FDA review"

GSK Enters Agreement to Acquire Nuvalent

GSK Enters Agreement to Acquire Nuvalent

GSK has agreed to acquire Nuvalent in a multi-product oncology deal that strengthens its lung cancer portfolio with two late-stage, potential best-in-class therapies—zidesamtinib and neladalkib—for non-small cell lung cancer.

US FDA Review | 10/06/2026 | By News Bureau

AstraZeneca and Daiichi Sankyo Secure US Food and Drug Administration Priority Review for Enhertu in HER2-Positive Breast Cancer

AstraZeneca and Daiichi Sankyo Secure US Food and Drug Administration Priority Review for Enhertu in HER2-Positive Breast Cancer

US Food and Drug Administration grants Priority Review to supplemental application for Enhertu to treat HER2-positive breast cancer patients with residual disease after neoadjuvant therapy, with decision expected in Q3 2026.

US FDA Review | 10/03/2026 | By News Bureau 141


 

 

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