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  • CDSCO (Central Drugs...

CDSCO (Central Drugs Standard Control Organisation) News - Page 16

AstraZeneca Koselugo recommended for approval in EU for plexiform neurofibromas in adults with neurofibromatosis type 1

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

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 Halol facility gets OAI status from USFDA

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...
Delhi ITAT Deletes Rs 14.98 Cr Ad-Hoc Disallowance on Mankind Pharmas Travel Expenses

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...
Novo Nordisk

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)...
Fludrocortisone 0.2 mg Study Rejected by CDSCO Panel Over Potential Adverse Effects

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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Indias Unique CV Risk Profile: How to Decode the Role of Aspirin?

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...

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

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

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

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

Negligence vs Misconduct: Where Do Medical Councils Draw the Line?

Negligence vs Misconduct: Where Do Medical Councils Draw the Line?

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Journal Club Today

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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Health Bulletin 11/October/2025

Health Bulletin 11/October/2025

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