Takeda said zasocitinib was generally well tolerated, with a safety profile consistent with earlier studies
The approval for Exdensur (depemokimab-ulaa) comes on the back of SWIFT-1 and SWIFT-2 Phase III trials
Efdoralprin alfa, a recombinant human alpha-1 antitrypsin (AAT)-Fc fusion protein, showed superior efficacy to standard plasma-derived therapy in adults with AATD
The approval comes with 180 days of Competitive Generic Therapy (CGT) exclusivity,
Travoprost ophthalmic solution is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension
The trial met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival
At one year, the drug met its primary and all key secondary endpoints, delivering significantly better weight maintenance than placebo
The study found BIC/LEN to be statistically non-inferior to BIKTARVY, Gilead’s current standard-of-care therapy
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