Drug Approval | November 14, 2025
Alembic receives USFDA final approval for Dexlansoprazole delayed-release capsules, 30 mg and 60 mg
Dexlansoprazole delayed-release capsules are a proton pump inhibitor
Dexlansoprazole delayed-release capsules are a proton pump inhibitor
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
The company has introduced an innovative Dual Release Proton Pump Inhibitor (PPI) tablet, a next-generation therapy for patients suffering from moderate to severe or treatment resistant gastroesophageal reflux disease
Everolimus is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients in kidney and liver transplantation
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
Sotyktu continues to demonstrate consistent efficacy and safety across rheumatic conditions
OS is a key secondary endpoint of the 948-patient study, which is evaluating whether adding AstraZeneca's PD-L1 inhibitor to standard FLOT chemotherapy
Global Phase 3 MANEUVER study highlights ongoing benefits and consistent safety profile
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