AstraZeneca & Daiichi Sankyo gain priority review for Datroway in hard-to-treat breast cancer
The FDA’s regulatory decision is expected in Q2 2026 under the Prescription Drug User Fee Act (PDUFA)
The FDA’s regulatory decision is expected in Q2 2026 under the Prescription Drug User Fee Act (PDUFA)
A final decision on the updated application is expected in the first half of 2026, while intravenous (IV) Saphnelo remains commercially available
The findings, based on an exploratory analysis, indicate that CD47 expression may predict which patients benefit most from the therapy
NATCO’s Erdafitinib is indicated for the treatment of adult patients with locally advanced unresectable or metastatic urothelial carcinoma harbouring susceptible FGFR3 genetic alteration
Venglustat, a glucosylceramide synthase inhibitor (GCSi), works by reducing the abnormal buildup of sugar-and-fat molecules in cells and organs
N17350 is the company’s first-in-class tumor-directed therapeutic, designed to harness the ELANE pathway
The study tested whether PF’3944 could maintain efficacy when switching from weekly to monthly injections and remain safe and well-tolerated
The approval follows the pivotal Phase III ARANOTE trial, which demonstrated that darolutamide plus ADT cut the risk of radiological progression or death by 46% compared to placebo plus ADT
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