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  • CDSCO (Central Drugs...

CDSCO (Central Drugs Standard Control Organisation) News - Page 3

CDSCO Panel Asks Takeda to Submit Full Phase III Data on Dengue Tetravalent Vaccine

CDSCO Panel Asks Takeda to Submit Full Phase III Data on Dengue Tetravalent Vaccine

Susmita Roy26 Sept 2025 4:21 PM IST
New 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

Bharat Biotech Gets SEC Nod to Begin Phase III Trial of Inactivated Chikungunya Vaccine

Susmita Roy26 Sept 2025 4:18 PM IST
New 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

CDSCO Tightens RTI Appeal Timelines, Division Heads to Face Penalties for Lapses

Susmita Roy25 Sept 2025 10:34 PM IST
New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has issued a fresh circular outlining internal timelines and procedures for...
Ravenbhel Gets SEC Nod to Market Bilastine, Montelukast FDC, Phase IV Trial Mandated

Syneos Health Asked to Clarify Phase II Tacrolimus Trial Protocol by CDSCO Panel

Susmita Roy25 Sept 2025 3:35 PM IST
New Delhi: Following a thorough review of the Phase II clinical study protocol for Tacrolimus (T1695), the Subject Expert Committee (SEC) functioning...
Zydus Gets CDSCO Panel Nod to Market Sodium Chloride Nebuliser Solution

Zydus Lifesciences Gets CDSCO Panel Nod for Bioavailability Study of Antimalarial Candidate ZY-19489

Parthika Patel25 Sept 2025 3:24 PM IST
New 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

CDSCO Panel Asks Astellas Pharma to Update Enzalutamide Label After Phase IV Study

Susmita Roy24 Sept 2025 5:27 PM IST
New 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

Intas Pharma Told to Revise Phase I, III Pembrolizumab Trial Protocol

Susmita Roy24 Sept 2025 2:00 PM IST
New Delhi: The Subject Expert Committee (SEC), functioning under the Central Drugs Standard Control Organisation (CDSCO), has asked Intas...
Asks Akums for Detailed Data on Phase III Eye Drop Trial

CDSCO Panel Asks Akums for Detailed Data on Phase III Eye Drop Trial

Parthika Patel23 Sept 2025 4:03 PM IST
New 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

CDSCO Panel Flags Trial Death, Seeks Causality Report from Reliance Life Sciences on EtanerRel

Susmita Roy22 Sept 2025 4:48 PM IST
New 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

Spurious Drugs Alert: Diazepam, PAN 40, and PAN-D Capsules Under Investigation

Susmita Roy22 Sept 2025 4:46 PM IST
New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has raised alarms over three batches of critical medicines, including anti-anxiety...
Biocon Biologics, Amgen strike settlement

Biocon Gets CDSCO Panel Nod to Import Aflibercept Injection for Eye Disorders, Phase IV Trial Mandated

Parthika Patel21 Sept 2025 3:30 PM IST
New 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

94 Drug, Medical Product Batches Fail CDSCO Quality Tests in August

Susmita Roy21 Sept 2025 3:30 PM IST
New Delhi: The Central Drugs Standard Control Organization (CDSCO) has identified 94 batches of medicines and medical products as "Not of Standard...
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India's Unique CV Risk Profile: How to Decode the Role of Aspirin?

Vildagliptin-Dapagliflozin FDC Effective in High CV Risk Indian T2DM Patients: Findings from Latest DAa-ViNCI Study

Vildagliptin-Dapagliflozin FDC Effective in High CV Risk Indian T2DM Patients: Findings from Latest...

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Tirzepatide proves to be more effective than semaglutide- Results of Surmount 5 Trial

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Pneumococcal Vaccination in Hematological Malignancies (HM)-Indian Hematology Expert Consensus 2025

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Genome Sequencing in Newborns May Identify Life-Threatening Disorders Missed by Traditional Tests: Study Shows

Genome Sequencing in Newborns May Identify Life-Threatening Disorders Missed by Traditional Tests:...

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