Drug Approval | March 22, 2025
SMS Pharmaceuticals completes USFDA inspection at Hyderabad facility
The inspection, conducted from March 17 to March 21, 2025, concluded with one observation in Form 483
The inspection, conducted from March 17 to March 21, 2025, concluded with one observation in Form 483
Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% (OTC), will be distributed in the US by Glenmark Therapeutics, USA.
Finerenone is the first drug targeting the mineralocorticoid receptor (MR) pathway to demonstrate cardiovascular benefits in a Phase III study in patients with heart failure
Apitoria Pharma’s API manufacturing facility classified as VAI by USFDA
The new office in New Delhi marks a significant funding in the APAC region and reinforces the company’s commitment to advancing respiratory care in India
This facility represents a significant step in Croda’s Pharma business strategy to ‘Empower biologics delivery’
Apalutamide is an androgen receptor inhibitor indicated for the treatment of patients with metastatic castration-sensitive prostate cancer
TB treatment coverage in India increased by 32% in the last eight years from 53% in 2015 to 85% in 2023
Talicia is also approved and launched in the UAE and additional countries may accept UK MHRA approvals as a reference for their own marketing approval processes
This program aims to develop a fully human monoclonal antibody against a novel immune checkpoint protein that enables T cell activation
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