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
Sepsis is a life-threatening reaction to infection that overwhelms the body’s defenses
The trial will evaluate safety endpoints including dose-limiting toxicities and adverse events
Novartis is the only pharmaceutical company with a dedicated commercial RLT portfolio
Cardiovascular disease (CVD) is the leading cause of death in the US and worldwide with over 82 million Americans living with CVD
Fenebrutinib targets cells in the immune system known as B cells and microglia
The partnership aims to develop novel, selective small molecules targeting TDP-43 pathology
The data highlight sustained intraocular pressure (IOP) reduction, drop-free treatment outcomes, and strong visual performance
OncoMate MSI Dx Analysis System is a PCR-based assay designed to evaluate MSI status in tumor tissue
The EIR follows a product-specific Pre-Approval Inspection from September 1 to September 5, 2025.
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