FDA reviews AstraZeneca’s Saphnelo for subcutaneous use in Lupus
A final decision on the updated application is expected in the first half of 2026, while intravenous (IV) Saphnelo remains commercially available
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
A PRV is a tradable voucher granted by the FDA to encourage the development of new treatments for rare pediatric diseases
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