Drug Approval | February 10, 2025
EMBLAVEOTM is the first and only monobactam/?-lactamase inhibitor combination antibiotic therapy approved by the USFDA
Akums Drugs & Pharmaceuticals has launched Dapagliflozin + Pioglitazone tablets, a dual-action therapy for diabetes management
Everolimus TFOS is a kinase inhibitor indicated in adult and paediatric patients aged one year and older with tuberous sclerosis complex for the treatment of subependymal giant cell astrocytoma
The company is committed to unlocking new frontiers in neuroscience and developing Usnoflast for patients with ALS
This study will enrol 210 ALS patients and study doses of 50 mg and 75 mg Usnoflast versus placebo
Based on ECHO Phase III trial results which showed more than 16 months of progression-free survival improvement vs. chemoimmunotherapy alone
Regulatory filings underway for a third indication for darolutamide in prostate cancer, for finerenone in a common form of heart failure, and acoramidis in transthyretin amyloid
If approved, sasanlimab would be the first PD-1 inhibitor, in combination with BCG, to significantly prolong event-free survival in this patient population
These three NDAs of Sitagliptin (base) and combination franchise have been approved by the USFDA earlier through the 505(b)(2) route
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