CDSCO Digitisation Cuts Post-Approval Change Timelines in CGTs from 218 to 98 Days: DCGI Parthika Patel22 Aug 2025 6:12 PM ISTNew Delhi: The Drug Controller General of India (DCGI), Central Drugs Standard Control Organisation (CDSCO), Dr Rajeev Raghuvanshi, has recently...
CDSCO Panel Approves Emcure's Phase III Clinical Trial of Semaglutide, Mandates Govt Trial Sites Susmita Roy21 Aug 2025 6:53 PM ISTNew Delhi: Accepting the bioequivalence (BE) study report, the Subject Expert Committee (SEC) functional under the Central Drugs Standard Control...
Revise Phase III Trial Protocol for Roflumilast Cream: CDSCO Panel Tells Sun Pharma Susmita Roy20 Aug 2025 4:20 PM ISTNew Delhi: Following a thorough discussion on the proposed Phase III clinical trial protocol for roflumilast cream, the Subject Expert Committee (SEC)...
Sun Pharma's Dapagliflozin, Glimepiride, Metformin FDC Fails to Secure CDSCO Panel Nod Over Safety, Utility Concerns Susmita Roy19 Aug 2025 3:11 PM ISTNew Delhi: Expressing doubts over the clinical utility of administering such a small dose of Glimepiride once daily, especially considering over the...
Submit BE Raw Data, Interaction Study on Dapagliflozin-Rosuvastatin FDC: Expert Panel Tells Pure and Cure Susmita Roy19 Aug 2025 3:02 PM ISTNew Delhi: In line with the proposal presented by Pure and Cure Healthcare for the Dapagliflozin plus Rosuvastatin film-coated tablet, the Subject...
Regulatory Roadblock for Zydus: CDSCO Panel Halts MMRV Vaccine Trial, Seeks Adult Data Dr. Divya Colin18 Aug 2025 4:15 PM ISTNew Delhi: Zydus Lifesciences Limited's plan to conduct a Phase II/III clinical trial of its Measles, Mumps, Rubella and Varicella (MMRV) vaccine has...
Expert Panel Rejects Zuventus' Trelagliptin PMS Plan, Seeks Higher Patient Enrolment Parthika Patel18 Aug 2025 2:37 PM ISTNew Delhi: Zuventus Healthcare Limited's proposal for the active post-marketing surveillance (PMS) study of Trelagliptin Tablets 25 mg, 50 mg and 100...
Bayer Gets CDSCO Committee Nod to Manufacture, Market Darolutamide 300 mg for mHSPC, PMS Study Mandated Susmita Roy18 Aug 2025 2:00 PM ISTNew Delhi: Bayer Pharmaceuticals has got the go-ahead from the Subject Expert Committee (SEC) functioning under the Central Drugs Standard Control...
Dr Reddy's Secures CDSCO Panel Approval to Import, Market Olutasidenib for AML Susmita Roy17 Aug 2025 4:00 PM ISTNew Delhi: In a significant development, the pharmaceutical major, Dr. Reddy's Laboratories, has got the go-ahead from the Subject Expert Committee...
Sun Pharma Gets SEC Nod to Conduct Phase III Trial of Resmetirom Tablets Dr. Divya Colin17 Aug 2025 3:00 PM ISTNew Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has recommended allowing Sun...
Lupin to Conduct BE Study for Synthetic Semaglutide Tablets in 3 Strengths Parthika Patel15 Aug 2025 3:02 PM ISTNew Delhi: Lupin Limited has received the green light from the Subject Expert Committee (SEC) under the Endocrinology & Metabolism division of the...
Sun Pharma Gets CDSCO Panel Nod for Active PMS of Fexuprazan Hydrochloride Tablets Susmita Roy15 Aug 2025 2:31 PM ISTNew Delhi: Sun Pharma Laboratories has got the go-ahead from the Subject Expert Committee (SEC) functioning under the Central Drugs Standard Control...
