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CDSCO (Central Drugs Standard Control Organisation) News - Page 2

MSD Pharma gets CDSCO panel nod for New Indications of Pembrolizumab in India

MSD Pharma gets CDSCO panel nod for New Indications of Pembrolizumab in India

Susmita Roy3 Oct 2025 8:36 PM IST
New Delhi: The Subject Expert Committee functioning under the Central Drugs Standard Control Organization (CDSCO) has granted approval for additional...
CDSCO Panel Directs Malik Lifesciences to Revise Phase III Trial Protocol for Tamsulosin, Dutasteride, Tadalafil FDC

CDSCO Panel Directs Malik Lifesciences to Revise Phase III Trial Protocol for Tamsulosin, Dutasteride, Tadalafil FDC

Parthika Patel3 Oct 2025 7:17 PM IST
New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) has directed Malik Lifesciences Pvt Ltd to...
SEC Recommends Phase III Trial of MSN Labs Vibegron Against Mirabegron in Overactive Bladder

MSN Lab gets CDSCO panel nod for Phase IV CT of Tofacitinib Tablets 10 mg

Susmita Roy2 Oct 2025 12:15 PM IST
New Delhi: The Subject Expert Committee (SEC) functioning under the Central Drugs Standard Control Organisation (CDSCO) has granted approval to MSN...
SEC Recommends Phase III Trial of MSN Labs Vibegron Against Mirabegron in Overactive Bladder

SEC Recommends Phase III Trial of MSN Labs' Vibegron Against Mirabegron in Overactive Bladder

Parthika Patel2 Oct 2025 10:30 AM IST
New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) has recommended granting permission to MSN...
Not All Combipacks Are New Drugs: CDSCO Defines Approval Rules for Lyophilized Injections

Not All Combipacks Are New Drugs: CDSCO Defines Approval Rules for Lyophilized Injections

Susmita Roy1 Oct 2025 4:50 PM IST
New Delhi: The Central Drugs Standard Control Organization (CDSCO) has issued a notice clarifying the regulatory pathway for approval of combipack...
Bombay HC Grants Relief to Sun Pharma in Trademark Battle Over Lupride

Bombay HC Quashes Maharashtra FDA, CDSCO Stop-Production Orders Against 2 Pharma Firms

Susmita Roy30 Sept 2025 4:08 PM IST
Mumbai: The Bombay High Court has struck down orders issued by the Maharashtra Food and Drug Administration (FDA) and the Central Drugs Standard...
Intas Pharma Told to Narrow Margins, Extend Duration in Pembrolizumab Trial Protocol

Intas Pharma Told to Narrow Margins, Extend Duration in Pembrolizumab Trial Protocol

Farhat Nasim30 Sept 2025 3:09 PM IST
New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has directed Intas Pharmaceuticals Ltd. to...
SEC Recommends Phase III Trial of MSN Labs Vibegron Against Mirabegron in Overactive Bladder

MSN Lab gets CDSCO panel nod for Phase IV CT of Tofacitinib Oral Solution

Susmita Roy29 Sept 2025 9:56 PM IST
New Delhi: The Subject Expert Committee (SEC) functioning under the Central Drugs Standard Control Organisation (CDSCO) has granted approval to MSN...
Himachal, UP Join States Banning Coldrif Cough Syrup After MP Deaths

Health Ministry Bans 34 Key Antibiotics, Antivirals for Animal Use, See List

Susmita Roy29 Sept 2025 9:51 PM IST
New Delhi: Through a recent Gazette notification, the Ministry of Health and Family Welfare has notified a ban on the import, manufacture, sale, and...
CDSCO Panel Recommends Updating Prescribing Information for Sanofis Vaccine

CDSCO Panel Recommends Updating Prescribing Information for Sanofi's Vaccine

Susmita Roy28 Sept 2025 1:15 PM IST
New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has recommended updation of the...
Not All Combipacks Are New Drugs: CDSCO Defines Approval Rules for Lyophilized Injections

CDSCO Panel Approves Novo Medi Sciences' Phase III Booster Study of PCV13 Pneumococcal Vaccine in Infants

Susmita Roy27 Sept 2025 6:13 PM IST
New Delhi: Reviewing the revised Phase III clinical trial protocol for booster dose administration of the 13-valent Pneumococcal Polysaccharide...
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...
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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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Your Social Connections Could Slow Down Biological Aging: Study Suggests

Your Social Connections Could Slow Down Biological Aging: Study Suggests

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Health Bulletin 10/October/2025

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