Drug Approval | November 10, 2025
Johnson & Johnson gets FDA nod for new depression treatment
This approval is based on positive results from two Phase 3, global, double-blind, placebo-controlled trials
This approval is based on positive results from two Phase 3, global, double-blind, placebo-controlled trials
The FDA setback highlights ongoing tensions between patient needs, regulatory processes, and the use of real-world evidence in evaluating treatments for rare diseases
Enzomenib, an oral, small-molecule inhibitor designed to disrupt the menin-MLL protein interaction involved in leukemogenesis
Orphan drug designation (ODD) by the USFDA for Desidustat, provides eligibility for a potential seven-year marketing exclusivity subject to the USFDA approval
Kulzer has consolidated the production of its core product, artificial teeth, at its facility in Germany
Approval based on pivotal KOMET Phase III trial demonstrating significant tumour reduction in adults with NF1
New Phase III data on gefurulimab highlight potential as a self-administered treatment option; real-world evidence reinforces clinical benefits of Ultomiris and Soliris
AI-powered cardiometabolic wellness platform for India’s workforce
Sotyktu continues to demonstrate consistent efficacy and safety across rheumatic conditions
Nicardipine Hydrochloride in 0.9% Sodium Chloride Injection is indicated for the short-term treatment of hypertension when oral therapy is not feasible or desirable
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