These results were consistent across all clinically relevant patient subgroups regardless of key patient characteristics like age or sex, the cause of stroke or the severity of the stroke
This Orphan Drug Designation from the USFDA underlines the urgent medical need to develop a therapy for sickle cell disease
The pharmaceutical giant said it would pursue legal and regulatory action following Hims & Hers
The PRIOH-1 study met its primary endpoint, delivering statistically significant and clinically meaningful improvements in lesion healing
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
Venglustat, a glucosylceramide synthase inhibitor (GCSi), works by reducing the abnormal buildup of sugar-and-fat molecules in cells and organs
The findings, based on an exploratory analysis, indicate that CD47 expression may predict which patients benefit most from the therapy
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
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