Nucala is the first and only monthly biologic in the EU evaluated in a wide COPD population with an eosinophilic phenotype
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
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
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
Venglustat, a glucosylceramide synthase inhibitor (GCSi), works by reducing the abnormal buildup of sugar-and-fat molecules in cells and organs
The recommendation covers FYLREVY 14.2 mg and 18.9 mg for non-hysterectomised postmenopausal women experiencing oestrogen deficiency symptoms at least 12 months after their last menses
The study tested whether PF’3944 could maintain efficacy when switching from weekly to monthly injections and remain safe and well-tolerated
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
The Poultry Healthcare Division delivered a strong performance, posting 32% revenue growth in Q3 FY26 and 17% growth over the nine-month period
Subscribe To Our Newsletter & Stay Updated
