Semaglutide—a glucagon?like peptide?1 receptor agonist (GLP-1RA) sold as Ozempic and Rybelsus for type 2 diabetes, and Wegovy for weight management and cardiovascular risk reduction
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
The PRIOH-1 study met its primary endpoint, delivering statistically significant and clinically meaningful improvements in lesion healing
Under the agreement, Apotex’s branded division, Searchlight Pharma, will seek regulatory approval and handle marketing and distribution in Canada
US revenue increased 43% to $12.9 billion, fueled by a 50% jump in volume, partially offset by a 7% decline in realized prices
The FDA’s regulatory decision is expected in Q2 2026 under the Prescription Drug User Fee Act (PDUFA)
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
Over a two-decade career, Dr. Berman has worked on more than a dozen clinical-stage immunotherapies, including senior leadership roles in developing four oncology biologics
Subscribe To Our Newsletter & Stay Updated
