Sponsor's proposal for a label warning, but not a black box, on retinopathy risk with the once-weekly GLP-1 agonist finds support from a US FDA advisory committee, which overwhelming endorsed approval for treatment of type 2 diabetes on the basis of robust glycemic control efficacy data and a strong cardiovascular safety profile.
A US FDA panel's recommendation for a retinopathy label warning on Novo Nordisk AS' semaglutide seems unlikely to dim the GLP-1 receptor agonist's commercial prospects given its robust glycemic control effects and reassuring cardiovascular safety profile.
At an Oct. 18 meeting, FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 16-0, with one abstention, that the efficacy...
Deal Snapshot: Jazz, which sells Epidiolex for rare seizure disorders, will pay $42.5m up front to take over development of Saniona’s preclinical Kv7.2/Kv7.3 activator SAN2355 for epilepsy.
Four days after Wegovy became the second approved MASH therapy in the US, Rezdiffra gets the first European approval. Plans are for an initial launch in Germany.
All eyes on chronic urticaria after eosinophilic esophagitis disappointment.
