Akum Pharma Asked to Submit Safety Data for Alzheimer's Drug Combo In Elderly Indian Patients Dr. Divya Colin5 Aug 2025 5:31 PM ISTNew Delhi: In a recent regulatory review, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO)...
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...
CDSCO Panel Recommends Approval for Vorasidenib with Phase-III Waiver, Mandates Phase-IV Trial in India Dr. Divya Colin3 Aug 2025 12:00 PM ISTNew Delhi: In response to a proposal by Servier India Pvt. Ltd. seeking approval to import and market the anti-cancer drug Vorasidenib Tablets 10 mg...
Novartis Told to Revise Protocol, Justify Sample Size in ITU512 Clinical Trial Proposal Parthika Patel3 Aug 2025 9:30 AM ISTNew Delhi: Novartis Healthcare Private Limited has been directed by the Subject Expert Committee (SEC) functional under the Central Drugs Standard...
Health Ministry Notifies Cosmetics Rules 2025, Empowers States To Suspend Licences Farhat Nasim2 Aug 2025 5:59 PM ISTNew Delhi: The Ministry of Health and Family Welfare has notified the Cosmetics (Amendment) Rules, 2025, making several key changes to the Cosmetics...
CDSCO Panel Accepts Phase I Trial Data for Intas' Denosumab Biosimilar Parthika Patel2 Aug 2025 4:40 PM ISTNew Delhi: The Subject Expert Committee (SEC) under the Analgesic and Rheumatology division of the Central Drugs Standard Control Organisation (CDSCO)...
CDSCO Panel Clears PURE & CURE's Sickle Cell Trial With Conditions On Sample Size, Sites Parthika Patel1 Aug 2025 5:09 PM ISTNew Delhi: PURE & CURE Healthcare Pvt. Ltd. has received a recommendation from the Subject Expert Committee (SEC) under the Central Drugs Standard...
Veeda Clinical Research Gets Expert Committee Nod To Conduct BA/BE Study Of Ibrutinib For Export Dr. Divya Colin1 Aug 2025 9:45 AM ISTNew Delhi: Veeda Clinical Research Limited got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
CDSCO Panel Withholds Nod for Syngene's Pegfilgrastim Trial, Seeks Additional Data Parthika Patel31 July 2025 2:01 PM ISTNew Delhi: The Subject Expert Committee under the Central Drugs Standard Control Organisation (CDSCO) has directed Syngene International Limited 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...
CDSCO Introduces QR Code System for Streamlined Visitor Entry Parthika Patel30 July 2025 3:53 PM ISTNew Delhi: The Central Drugs Standard Control Organisation (CDSCO) has launched a new QR code-based online appointment system to simplify the process...
