This Orphan Drug Designation from the USFDA underlines the urgent medical need to develop a therapy for sickle cell disease
HYMPAVZI is already approved in the US for patients 12 and older with hemophilia A without factor VIII inhibitors or hemophilia B without factor IX inhibitors
Hologic has been at the forefront of cervical cancer screening for decades
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
The facility is dedicated to breakthrough innovations in laboratory instruments that detect infectious diseases, cancer, and blood disorders
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
TB Alliance will continue to lead clinical development, while Lupin will leverage its global manufacturing, regulatory, and supply chain expertise to ensure the drug reaches patients worldwide
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