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CDSCO (Central Drugs Standard Control Organisation) News - Page 19

Zydus Told To Conduct Phase III Trial in India for Lurbinectedin Injection, BE Study Waived

Zydus Told To Conduct Phase III Trial in India for Lurbinectedin Injection, BE Study Waived

Parthika Patel31 July 2025 1:49 PM IST
New Delhi: Zydus Lifesciences Limited has been directed to conduct a Phase III clinical trial in the Indian population for its proposed oncology drug...
Centre Mandates QR Codes for Top Medicines, APIs: Minister

CDSCO Introduces QR Code System for Streamlined Visitor Entry

Parthika Patel30 July 2025 3:53 PM IST
New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has launched a new QR code-based online appointment system to simplify the process...
Ranitidine Under Cancer Cloud: CDSCO Calls for Monitoring NDMA Levels, Shelf Life Cuts

Ranitidine Under Cancer Cloud: CDSCO Calls for Monitoring NDMA Levels, Shelf Life Cuts

Parthika Patel28 July 2025 6:27 PM IST
New Delhi: The Central Drugs Standard Control Organization (CDSCO), under the Directorate General of Health Services, has issued a directive to all...
Odisha Pharma Summit 2025 on December 16; policy launch, parks expected

Expert Committee Clears Ravenbhel to Begin Resmetirom Phase 3 Trial, Asks for BE Data First

Parthika Patel27 July 2025 4:00 PM IST
New Delhi: The Subject Expert Committee (SEC) under the Gastroenterology and Hepatology division of the Central Drugs Standard Control Organisation...
Troikaas Fast-Acting Paracetamol Shot Hits Regulatory Hurdle, CDSCO Panel Seeks More Data

Troikaa's Fast-Acting Paracetamol Shot Hits Regulatory Hurdle, CDSCO Panel Seeks More Data

Dr. Divya Colin27 July 2025 3:00 PM IST
New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has asked Troikaa Pharmaceuticals Ltd. to...
CDSCO Panel Seeks Safety Data on 5% Lenalidomide TDS Before Clearing 8% Patch Trial

CDSCO Panel Seeks Safety Data on 5% Lenalidomide TDS Before Clearing 8% Patch Trial

Parthika Patel25 July 2025 4:38 PM IST
New Delhi: The Subject Expert Committee (SEC) under the Oncology division of the Central Drugs Standard Control Organisation (CDSCO) has not granted...
CDSCO Panel Approves Phase IV Protocol Amendment for Bristol-Myers Squibbs Mavacamten Study

CDSCO Panel Approves Phase IV Protocol Amendment for Bristol-Myers Squibb's Mavacamten Study

Parthika Patel24 July 2025 6:49 PM IST
New Delhi: The Subject Expert Committee (SEC) under the Cardiovascular division of the Central Drugs Standard Control Organisation (CDSCO) has...
Eris Lifesciences Secures CDSCO Panel Nod to Conduct BE Study on Dapagliflozin, Pioglitazone, Metformin FDC

Eris Gets CDSCO Panel Nod To Dapagliflozin-Bisoprolol-Sacubitril Valsartan Combo Kit, Phase IV Trial Mandated

Parthika Patel23 July 2025 7:41 PM IST
New Delhi: The Subject Expert Committee (SEC) under the Cardiovascular division of the Central Drugs Standard Control Organisation (CDSCO) has...
Cipla to buy 100 percent stake in Inzpera Healthsciences for Rs 110.65 crores

CDSCO Panel Clears Cipla's Glycopyrronium-Formoterol Inhaler for Phase IV Trial

Dr. Divya Colin23 July 2025 5:00 PM IST
New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has granted Cipla Limited approval to...
Zydus Secures CDSCO Panel Go-Ahead For Phase III Trial of Empagliflozin-Metoprolol FDC

Zydus Secures CDSCO Panel Go-Ahead For Phase III Trial of Empagliflozin-Metoprolol FDC

Parthika Patel22 July 2025 6:19 PM IST
New Delhi: The Subject Expert Committee (SEC) under the Cardiovascular division of the Central Drugs Standard Control Organisation (CDSCO) has...
1-Year Ban for Fake Docs, Mandatory Disposal of Near-Expiry Stock: CDSCO Revises Pharma Export Rules

1-Year Ban for Fake Docs, Mandatory Disposal of Near-Expiry Stock: CDSCO Revises Pharma Export Rules

Farhat Nasim21 July 2025 11:51 PM IST
New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has issued a revised guidance document detailing the procedure for the issuance of...
MSD Pharma Gets Conditional SEC Approval to Begin Phase III Trial of Sacituzumab Tirumotecan

CDSCO Panel Nod To MSD's Sotatercept Label Change, Expands Prescribing Rights to Cardiologists

Parthika Patel21 July 2025 10:32 PM IST
New Delhi: The Subject Expert Committee (SEC) under Central Drugs Standard Control Organisation's (CDSCO) Cardiovascular division has approved MSD...
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Real-World Outcomes of Dydrogesterone ER 20 mg in Recurrent Pregnancy Loss

Real-World Outcomes of Dydrogesterone ER 20 mg in Recurrent Pregnancy Loss

Uncontrolled T2DM in India and Application of Trusted Molecules Empagliflozin, Sitagliptin, and Metformin Coming Together

Uncontrolled T2DM in India and Application of Trusted Molecules Empagliflozin, Sitagliptin, and...

The 1st Tooth Crosstalk | Episode 1 | The First Tooth - Where Oral Health Begins

The 1st Tooth Crosstalk | Episode 1 | The First Tooth - Where Oral Health Begins

Participation of the incarcerated in Clinical Trials in India: Need for a road map -Albina Arjuman

Participation of the incarcerated in Clinical Trials in India: Need for a road map -Albina Arjuman

Managing GERD in Children with Asthma with H2 receptor antagonists (H2RAs): Indian Paediatricians Perspectives

Managing GERD in Children with Asthma with H2 receptor antagonists (H2RAs): Indian Paediatricians'...

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Reassure Study: The Real-World Evidence Initiative in Recurrent early pregnancy loss

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Health Bulletin 18/December/2025

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