Syneos Health Asked to Clarify Phase II Tacrolimus Trial Protocol by CDSCO Panel Susmita Roy25 Sept 2025 3:35 PM ISTNew Delhi: Following a thorough review of the Phase II clinical study protocol for Tacrolimus (T1695), the Subject Expert Committee (SEC) functioning...
Zydus Lifesciences Gets CDSCO Panel Nod for Bioavailability Study of Antimalarial Candidate ZY-19489 Parthika Patel25 Sept 2025 3:24 PM ISTNew Delhi: The Subject Expert Committee (SEC) on Investigational New Drugs under the Central Drugs Standard Control Organisation (CDSCO) has...
CDSCO Panel Asks Astellas Pharma to Update Enzalutamide Label After Phase IV Study Susmita Roy24 Sept 2025 5:27 PM ISTNew Delhi: The Subject Expert Committee (SEC) functioning under the Central Drugs Standard Control Organisation (CDSCO), has opined Astellas Pharma...
Intas Pharma Told to Revise Phase I, III Pembrolizumab Trial Protocol Susmita Roy24 Sept 2025 2:00 PM ISTNew Delhi: The Subject Expert Committee (SEC), functioning under the Central Drugs Standard Control Organisation (CDSCO), has asked Intas...
CDSCO Panel Asks Akums for Detailed Data on Phase III Eye Drop Trial Parthika Patel23 Sept 2025 4:03 PM ISTNew Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) has sought additional clarifications from...
CDSCO Panel Flags Trial Death, Seeks Causality Report from Reliance Life Sciences on EtanerRel Susmita Roy22 Sept 2025 4:48 PM ISTNew Delhi: Noting that there was one death during the trial, the Subject Expert Committee (SEC), functional under the Central Drugs Standard Control...
Spurious Drugs Alert: Diazepam, PAN 40, and PAN-D Capsules Under Investigation Susmita Roy22 Sept 2025 4:46 PM ISTNew Delhi: The Central Drugs Standard Control Organisation (CDSCO) has raised alarms over three batches of critical medicines, including anti-anxiety...
Biocon Gets CDSCO Panel Nod to Import Aflibercept Injection for Eye Disorders, Phase IV Trial Mandated Parthika Patel21 Sept 2025 3:30 PM ISTNew Delhi: Biocon Biologics Limited has received recommendations from the Subject Expert Committee (SEC) under the Central Drugs Standard Control...
94 Drug, Medical Product Batches Fail CDSCO Quality Tests in August Susmita Roy21 Sept 2025 3:30 PM ISTNew Delhi: The Central Drugs Standard Control Organization (CDSCO) has identified 94 batches of medicines and medical products as "Not of Standard...
Sun Pharma Told to Limit Phase III Revefenacin Study to Triple Therapy COPD Patients Susmita Roy20 Sept 2025 7:04 PM ISTNew Delhi: Recommending to revise the inclusion criteria so that subjects on triple therapy only shall be included in the study, the Subject Expert...
Box Warning, Dose Limits: India Set To Tighten Nimesulide Use Susmita Roy19 Sept 2025 5:29 PM ISTNew Delhi: The Central Government has instructed pharmaceutical companies to include a prominent "Box Warning" on the widely used painkiller...
CDSCO, ICMR Release Standard Evaluation Protocols for Diagnostic Kits in India Susmita Roy19 Sept 2025 5:02 PM ISTNew Delhi: In a major step towards strengthening diagnostic quality in India, the Indian Council of Medical Research (ICMR) and the Central Drugs...
