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  • CDSCO (Central Drugs...

CDSCO (Central Drugs Standard Control Organisation) News - Page 26

AstraZeneca Pharma India Slapped Rs 11.88 Cr Tax Adjustment for FY23, to Move ITAT

AstraZeneca's Oral PCSK9 Inhibitor AZD0780 Cleared for Phase III Trial by CDSCO Panel

Dr. Divya Colin22 Jun 2025 9:30 AM IST
New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has granted approval to AstraZeneca Pharma...
CDSCO Declares 74 Medicines, APIs and Devices Samples Not of Standard Quality in December

58 Drug Batches, Including Dexona Fail CDSCO Quality Standards

Farhat Nasim21 Jun 2025 8:08 PM IST
New Delhi: In its continued effort to ensure drug safety and compliance, the Central Drugs Standard Control Organisation (CDSCO) has flagged 58...
Sun Pharma Names Sana Shaikh as Head of Marketing

Sun Pharma Gets Relief on Packaging Norms for Pantoprazole-Levosulpiride FDC

Parthika Patel21 Jun 2025 4:18 PM IST
New Delhi: In a regulatory relief to the company, the Subject Expert Committee (SEC) under the Gastroenterology and Hepatology division of the Central...
CDSCO Panel Directs Mankind Pharma to Conduct Phase I Trial of Sintilimab Before Phase III Launch

Mankind Pharma Gets CDSCO Panel Nod to Conduct Phase III Trial of Resmetirom Tablets

Parthika Patel21 Jun 2025 11:45 AM IST
New Delhi: The Subject Expert Committee (SEC) under the Gastroenterology and Hepatology division of the Central Drugs Standard Control Organisation...
Zydus Secures CDSCO Panel Go-Ahead For Phase III Trial of Empagliflozin-Metoprolol FDC

Zydus Gets CDSCO Panel Nod to Conduct Phase IV Trial for Indacaterol-Budesonide FDC Inhalation

Dr. Divya Colin20 Jun 2025 11:45 PM IST
New Delhi: In response to the proposal presented by Zydus Healthcare, the Subject Expert Committee (SEC) functional under the Central Drug Standard...
CDSCO Panel Flags Trial Death, Seeks Causality Report from Reliance Life Sciences on EtanerRel

CDSCO Panel Rejects Phase II Data for Reliance's RelCoVax COVID-19 Booster Over Immunogenicity Gap

Parthika Patel19 Jun 2025 7:53 PM IST
New Delhi: The Subject Expert Committee (SEC) on COVID-19 vaccines, operating under the Central Drugs Standard Control Organisation (CDSCO), has...
Pill form of Wegovy gets USFDA approval for weight loss

Novo Nordisk Told to Increase Indian Patient Enrollment for Ziltivekimab Study

Dr. Divya Colin19 Jun 2025 7:36 PM IST
New Delhi: In response to a proposal by Novo Nordisk, the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO)...
CDSCO Panel Declines to Consider ACME Generics Phase IV Trial Results for Liothyronine Tablets

Exemed's Sitagliptin FDC Hits Roadblock as CDSCO Panel Flags No Added Safety Benefit

Parthika Patel18 Jun 2025 5:53 PM IST
New Delhi: In a setback for Exemed Pharmaceutical, the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO)...
Fresenius Told to Submit Global Data for Calcium Chloride Infusion Approval

Fresenius Told to Submit Global Data for Calcium Chloride Infusion Approval

Parthika Patel18 Jun 2025 4:36 PM IST
New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has asked Fresenius Medical Care India...
Intas Pharma, Accord signs agreement to buy Prothya Biosolutions

Intas Gets CDSCO Panel Nod to Conduct Phase III Trial of Semaglutide Injection for Weight Management

Parthika Patel17 Jun 2025 6:30 PM IST
New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has accepted the Bioequivalence (BE)...
Windlas Biotech Gets SEC Nod to Manufacture Dapagliflozin-Pioglitazone FDC

Windlas Biotech Gets SEC Nod to Manufacture Dapagliflozin-Pioglitazone FDC

Parthika Patel17 Jun 2025 6:20 PM IST
New Delhi: The Subject Expert Committee (SEC) for Endocrinology & Metabolism under the Central Drugs Standard Control Organisation (CDSCO) has...
Dr Reddys Gets CDSCO Panel Nod To Import, Market Saccharomyces Boulardii, BE, CT Waived

Dr Reddy's Gets CDSCO Panel Nod To Import, Market Saccharomyces Boulardii, BE, CT Waived

Dr. Divya Colin15 Jun 2025 12:30 PM IST
New Delhi: Granting the bioequivalence study waiver and clinical trial study waiver, the Subject Expert Committee (SEC) functional under the Central...
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Editorial

Robust Glycemic Control & Cardio-Renal Protection: Meeting the Advanced Needs of Indian Uncontrolled T2D with Empagliflozin, Sitagliptin, Metformin

Robust Glycemic Control & Cardio-Renal Protection: Meeting the Advanced Needs of Indian Uncontrolled...

Evaluation of Biologic Efficacy and Cost per NNT in Moderate-to-Severe Psoriasis: Indian Analysis

Evaluation of Biologic Efficacy and Cost per NNT in Moderate-to-Severe Psoriasis: Indian Analysis

U.S. FDA Grants Approval for Ranitidine Comeback

U.S. FDA Grants Approval for Ranitidine Comeback

Dapagliflozin and Sitagliptin FDC in T2D with Heart Failure: 2025 Indian Practice Review

Dapagliflozin and Sitagliptin FDC in T2D with Heart Failure: 2025 Indian Practice Review

Importance of Early Aggressive Glucose Control - Approach in 2026

Importance of Early Aggressive Glucose Control - Approach in 2026

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Journal Club Today

Lowering Sodium in Everyday Foods Could Help Prevent Heart Disease, Stroke: Study

Lowering Sodium in Everyday Foods Could Help Prevent Heart Disease, Stroke: Study

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Health News Today

Health Bulletin 28/January/2026

Health Bulletin 28/January/2026

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