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
Tinostamustine is an investigational drug with a potential first-in-class mechanism combining bifunctional alkylating activity and pan histone deacetylase (HDAC) inhibition
Relmada expects to initiate its Phase 3 program in the first half of 2026
The FDA setback highlights ongoing tensions between patient needs, regulatory processes, and the use of real-world evidence in evaluating treatments for rare diseases
Sumatriptan injection is indicated in adults for the acute treatment of migraine
The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Sprycel Tablets
Ticagrelor tablets are indicated for reducing the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients
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
Triamcinolone Acetonide injectable suspension USP is indicated for various autoimmune, inflammatory, and other conditions
These findings follow positive Phase 3 results presented earlier this year
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