Neil Dahiya

Neo Medical Achieves Full European Approval for Spine Care Platform Under New EU Medical Device Regulations

Neo Medical SA, a pioneering Swiss firm in spinal surgery technology, has proudly announced that its full suite of products has gained approval under the European Union’s updated Medical Device Regulation (MDR) EU 2017/745. This accomplishment underscores the company’s adherence […]

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Renalys Pharma’s Sparsentan Earns Japan’s Orphan Drug Status for Treating Primary IgA Nephropathy

Renalys Pharma, Inc., a biopharmaceutical company advancing in late-stage clinical trials, has announced that its drug sparsentan, acquired from Travere Therapeutics, Inc. (Travere), currently undergoing phase III studies in Japan, has been granted Orphan Drug Designation by Japan’s Ministry of

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Hong Kong Accepts NDA Submission for Velsipity to Manage Severe Ulcerative Colitis by Everest Medicines

Everest Medicines, a prominent biopharmaceutical firm dedicated to pioneering drug discovery, clinical progress, production, and bringing novel treatments to market, announced the Hong Kong Special Administrative Region’s Department of Health has accepted their New Drug Application (NDA) for Velsipity (etrasimod).

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MSMEs Prepared to Implement Updated Schedule M for Enhancing Drug Quality, Says Dr. H.G. Koshia

Dr. H.G. Koshia, Commissioner of Gujarat FDCA, has announced that Indian Pharma MSMEs are adopting the Revised Schedule M guidelines with greater enthusiasm. They are preparing to develop a comprehensive Pharmaceutical Quality System (PQS), integrate Quality Risk Management (QRM), conduct

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NPPA Updates Draft Pricing Document for Glenmark’s Cardiac Medication Post Review Directive

Following a directive from the Department of Pharmaceuticals (DoP) in October, the National Pharmaceutical Pricing Authority (NPPA) has updated the draft pricing document concerning the retail price of Glenmark Pharmaceuticals’ cardiovascular medication, which combines cilnidipine 20 mg and telmisartan 40

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DGTR Examines Anti-Dumping Inquiry into China’s Siloxane Polyoxyalkylene Copolymer Imports

The Directorate General of Trade Remedies (DGTR) is currently assessing the parameters of the Product Under Consideration (PUC) and the utilization of the Product Control Numbers (PCN) approach in an ongoing investigation into allegations of anti-dumping related to siloxane polyoxyalkylene

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