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...
Fresenius Told to Submit Global Data for Calcium Chloride Infusion Approval Parthika Patel18 Jun 2025 4:36 PM ISTNew Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has asked Fresenius Medical Care India...
Elinzanetant Significantly Reduces Vasomotor Symptoms in Women on Endocrine Therapy: NEJM Dr Riya Dave10 Jun 2025 9:15 AM ISTA recent study published in The New England Journal of Medicine has found that elinzanetant, a therapy targeted at neurokinin receptors, significantly...
CDSCO Panel Asks Novartis to Submit Revised Protocol, Dose Changes for Ianalumab Phase III Trial Dr. Divya Colin1 Jun 2025 4:00 PM ISTNew Delhi: Reviewing the Phase III clinical of the Ianalumab (VAY736) presented by Novartis, the Subject Expert Committee (SEC) functional under the...
Bayer Gets CDSCO Panel Nod To Conduct Phase 3 Trial for Finerenone Dr. Divya Colin31 May 2025 5:56 PM ISTNew Delhi: Bayer Pharmaceutical has received approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Hetero Labs gets CDSCO Panel nod to study Tegoprazan tablet 50 mg Dr. Divya Colin13 May 2025 5:45 PM ISTNew Delhi: Responding to the proposal presented by Hetero Labs, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
