Drug Approval | January 24, 2025
Shilpa Pharma Lifesciences received CEP from EDQM for API, Teriflunomide
Teriflunomide is a novel disease-modifying agent that was approved for use in the treatment of multiple sclerosis
Teriflunomide is a novel disease-modifying agent that was approved for use in the treatment of multiple sclerosis
The Emcure Research Centre (ERC) will drive research across multiple dosage forms, including OSD, injectables, novel drug delivery systems (NDDS), inhalers and topical and transdermal formulations
The company plans to fund this Capex through debt and internal accruals and expects the project to be completed by FY27
The company is committed to unlocking new frontiers in neuroscience and developing Usnoflast for patients with ALS
Expand the scope of the Production-Linked Incentive (PLI) scheme and increase its allocation to cover more pharmaceutical products and raw materials
This study will enrol 210 ALS patients and study doses of 50 mg and 75 mg Usnoflast versus placebo
Datroway is the eighth new medicine of the 20 AstraZeneca has set out to deliver by 2030
Based on ECHO Phase III trial results which showed more than 16 months of progression-free survival improvement vs. chemoimmunotherapy alone
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Rexulti Tablets
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
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