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CDSCO (Central Drugs Standard Control Organisation) News - Page 30

Mankind Pharma Gets Relief as CGST Appellate Authority Drops Rs 1.02 Cr Penalty

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

Written By Dr. Kamal Kant Kohli21 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

Written By 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

Written By Dr. Kamal Kant Kohli19 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

Written By 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

Written By Dr. Kamal Kant Kohli18 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

Written By Dr. Kamal Kant Kohli18 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

Written By Dr. Kamal Kant Kohli17 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

Written By 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...
Gufic Bioscience Told To Submit More Data for Piperacillin-Tazobactam-Sodium Chloride FDC

Gufic Bioscience Told To Submit More Data for Piperacillin-Tazobactam-Sodium Chloride FDC

Written By Dr. Divya Colin15 Jun 2025 9:30 AM IST
New Delhi: In response to the proposal presented by Gufic Bioscience, the Subject Expert Committee (SEC) functional under the Central Drug Standard...
Abbott Volt Pulsed Field Ablation System bags USFDA approval for atrial fibrillation

SEC Asks Abbott to Submit More Data on Vitamin C Plus D3 FDC Chewable Tablet, Cites Lack of Justification

Written By Dr. Divya Colin14 Jun 2025 6:19 PM IST
New Delhi: In response to the proposal presented by Abbott, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
CDSCO Panel Accepts Mylans Post-Marketing Surveillance Report for Liposomal Amphotericin B Injection

CDSCO Panel Accepts Mylan's Post-Marketing Surveillance Report for Liposomal Amphotericin B Injection

Written By Dr. Divya Colin14 Jun 2025 6:00 PM IST
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has recommended to accept the...
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Timely Identification of Alzheimers Disease: Bridging the Diagnostic Gap and the Role of Biomarkers

Timely Identification of Alzheimer's Disease: Bridging the Diagnostic Gap and the Role of Biomarkers

Metformin: Anchor in the Metabolic Journey of Prediabetes Care- Dr Dwaipayan Deb

Metformin: Anchor in the Metabolic Journey of Prediabetes Care- Dr Dwaipayan Deb

Strengthening Adult Immunization in India: PCV20 and the Changing Landscape of Pneumococcal Disease Prevention

Strengthening Adult Immunization in India: PCV20 and the Changing Landscape of Pneumococcal Disease...

Efficacy and Safety of Injectable Semaglutide in Indian Patients with Type 2 Diabetes: Findings from a Phase III Study Presented at IDS 2026

Efficacy and Safety of Injectable Semaglutide in Indian Patients with Type 2 Diabetes: Findings from...

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