CDSCO Panel Approves Novo Medi Sciences' Phase III Booster Study of PCV13 Pneumococcal Vaccine in Infants Susmita Roy27 Sept 2025 6:13 PM ISTNew Delhi: Reviewing the revised Phase III clinical trial protocol for booster dose administration of the 13-valent Pneumococcal Polysaccharide...
CDSCO Panel Asks Takeda to Submit Full Phase III Data on Dengue Tetravalent Vaccine Susmita Roy26 Sept 2025 4:21 PM ISTNew Delhi: Reviewing India specific blinded interim safety analysis report of the ongoing Phase III clinical trial of Dengue tetravalent vaccine...
Bharat Biotech Gets SEC Nod to Begin Phase III Trial of Inactivated Chikungunya Vaccine Susmita Roy26 Sept 2025 4:18 PM ISTNew Delhi: Noting the results of the Phase II trial for the Inactivated Chikungunya vaccine, the Subject Expert Committee (SEC) functioning under the...
CDSCO Tightens RTI Appeal Timelines, Division Heads to Face Penalties for Lapses Susmita Roy25 Sept 2025 10:34 PM ISTNew Delhi: The Central Drugs Standard Control Organisation (CDSCO) has issued a fresh circular outlining internal timelines and procedures for...
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...
