Intas Pharma Gets Expert Panel Nod For PMS Data On Tofacitinib Ointment In Atopic Dermatitis Parthika Patel9 Aug 2025 11:30 AM ISTNew Delhi: Intas Pharma has received approval from the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO)...
Abbott to Conduct BE Study for Carbimazole 15 mg, Trial Waiver Granted In India Parthika Patel8 Aug 2025 2:34 PM ISTNew Delhi: Abbott Healthcare Pvt. Ltd has received the green signal from the Subject Expert Committee (SEC) under the Central Drugs Standard Control...
Pfizer Gets Expert Panel Nod to Update Etanercept Pre-Filled Injection Label Susmita Roy8 Aug 2025 2:08 PM ISTNew Delhi: Following a thorough review of post-marketing safety data, published literature, and clinical trial findings, the Subject Expert Committee...
CDSCO Committee Asks Elevate Scientific To Prove Back Pain Gel In Indian Trial Susmita Roy7 Aug 2025 11:55 PM ISTNew Delhi: With an aim to demonstrate the safety and efficacy on lower back pain, the Subject Expert Committee (SEC) functioning under the Central...
Dr Reddy's Gets CDSCO Panel Approval To Begin Phase III Trial of Tapinarof Cream Parthika Patel7 Aug 2025 11:41 PM ISTNew Delhi: Dr. Reddy's Laboratories Limited has received approval from the Subject Expert Committee (SEC) under CDSCO to conduct a Phase III clinical...
No Ban on Paracetamol, Says Govt; 156 Drug Combos Axed Over Safety Concerns Farhat Nasim7 Aug 2025 7:41 PM ISTNew Delhi: While 156 fixed-dose combinations (FDCs), including some involving Paracetamol, have been banned in public interest, the standalone drug...
No Waiver for Faricimab: CDSCO Panel Asks Roche to Conduct Phase III Trial in India Parthika Patel6 Aug 2025 3:34 PM ISTNew Delhi: Roche Products (India) Pvt Ltd has been directed by the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation...
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...
