CDSCO Panel Asks Wockhardt to Revise Phase III Study Protocol for Nafithromycin, Seeks Dosing, Control Arm Changes Susmita Roy16 Sept 2025 8:01 PM ISTNew Delhi: The Subject Expert Committee (SEC), which functions under the Central Drugs Standard Control Organisation (CDSCO), has recommended...
Insufficient Efficacy, Safety Data: CDSCO Panel Rejects Zydus' Phase III CT Waiver Request for Voclosporin Susmita Roy13 Sept 2025 6:13 PM ISTNew Delhi: Citing lack of sufficient efficacy and safety data to prove that the dose requirement in the Indian population is adequate, the Subject...
Pembrolizumab Significantly Improves Event-Free Survival in Head and Neck Cancer: NEJM Dr Riya Dave29 Aug 2025 10:15 PM ISTAccording to a recent study adding perioperative pembrolizumab to standard therapy such as surgery and radiotherapy with or without cisplatin...
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)...
Emcure Pharma Gets CDSCO Panel Nod for Phase III Trial of Semaglutide in Chronic Weight Management Susmita Roy13 Aug 2025 5:39 PM ISTNew Delhi: Accepting the bioequivalence (BE) study report, the Subject Expert Committee (SEC) functional under the Central Drugs Standard Control...
Abiogenesis Clinpharm To Conduct Phase III Trial of UTI Drug Phenazopyridine Susmita Roy10 Aug 2025 11:15 AM ISTNew Delhi: The Subject Expert Committee (SEC), functional under the Central Drugs Standard Control Organisation (CDSCO), has granted approval to...
MSN Labs Gets CDSCO Panel Nod to Begin Phase III Trial of Cenobamate Tablets, With Safety Caveat Dr. Divya Colin5 Aug 2025 4:15 PM ISTNew Delhi: Considering the bioequivalence study results of the MSN Labs Cenobamate Tablets 12.5 mg, 25 mg, 50mg, 100 mg, 150 mg & 200 mg, the...
Setback To Novartis: CDSCO Panel Rejects Lanalumab Phase III Trial Design Over Study Flaws Dr. Divya Colin4 Aug 2025 6:00 PM ISTNew Delhi: In a setback to Novartis, the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has declined to...
Zydus Told To Conduct Phase III Trial in India for Lurbinectedin Injection, BE Study Waived Parthika Patel31 July 2025 1:49 PM ISTNew Delhi: Zydus Lifesciences Limited has been directed to conduct a Phase III clinical trial in the Indian population for its proposed oncology drug...
Expert Committee Clears Ravenbhel to Begin Resmetirom Phase 3 Trial, Asks for BE Data First Parthika Patel27 July 2025 4:00 PM ISTNew Delhi: The Subject Expert Committee (SEC) under the Gastroenterology and Hepatology division of the Central Drugs Standard Control Organisation...
Once-Weekly Semaglutide-Insulin Combo Matches Daily Basal-Bolus in Type 2 Diabetes Control: Study Dr Riya Dave25 July 2025 9:30 AM ISTAccording to a Phase 3 trial published in The Lancet Diabetes & Endocrinology, a once-weekly combination of semaglutide and insulin icodec was...
Zydus Asked to Revise Phase III Trial Protocol for Cough Syrup FDC After CDSCO Panel Review Dr. Divya Colin18 July 2025 9:52 PM ISTNew Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has recommended key revisions to the Phase...
