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  • CDSCO (Central Drugs...

CDSCO (Central Drugs Standard Control Organisation) News - Page 27

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

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

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

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...
Intas Pharma, Accord signs agreement to buy Prothya Biosolutions

Intas Gets CDSCO Panel Nod to Conduct Phase III Trial of Pertuzumab Biosimilar for Breast Cancer

Dr. Divya Colin11 Jun 2025 5:45 PM IST
New Delhi: Intas Pharmaceuticals has received approval from the Subject Expert Committee (SEC), functioning under the Central Drugs Standard...
Lupin Expands GLP-1 Portfolio with Galenicum Semaglutide Deal

Lupin's TB Drug Isoniazid Dispersible Tablets Cleared for Launch by CDSCO Panel

Dr. Divya Colin10 Jun 2025 5:30 PM IST
New Delhi: In response to a proposal submitted by Lupin Limited, the Subject Expert Committee (SEC) operating under the Central Drugs Standard Control...
Bayer-Regeneron Aflibercept 8 mg recommended for EU approval for third retinal indication

CDSCO Panel Approves Bayer's Real-World Use Study for Heart Failure Drug Vericiguat

Dr. Divya Colin8 Jun 2025 12:56 PM IST
New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has granted approval to Bayer...
AstraZeneca Pharma India Slapped Rs 11.88 Cr Tax Adjustment for FY23, to Move ITAT

CDSCO Panel Approves Updated Prescribing Information for AstraZeneca's Rosuvastatin (Crestor)

Dr. Divya Colin8 Jun 2025 12:43 PM IST
New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has granted approval for the updated...
SEC Approves Serums Salk Polio Vaccine for Commercial Use, Recommends Phase I Trial for 21-valent Pneumococcal Vaccine

SEC Approves Serum's Salk Polio Vaccine for Commercial Use, Recommends Phase I Trial for 21-valent Pneumococcal Vaccine

Parthika Patel5 Jun 2025 6:17 PM IST
New Delhi: The Subject Expert Committee (SEC) on Vaccines under the Central Drugs Standard Control Organization (CDSCO) has recommended the conduct of...
Antibiotics May Soon Carry Blue Strip as Health Ministry Moves to Fight AMR

CDSCO Panel Seeks Revised Protocol for Green Signal's BCG Vaccine PMS Study

Parthika Patel5 Jun 2025 10:45 AM IST
New Delhi: The Subject Expert Committee (SEC) on Vaccines, operating under the Central Drugs Standard Control Organization (CDSCO), has reviewed the...
Alert does not reflect current situation: Indian Immunologicals on fake Abhayrab claims

CDSCO Panel Recommends Phase III Trial of Tetanus Vaccine by Indian Immunologicals in Pregnant Women

Parthika Patel4 Jun 2025 3:33 PM IST
New Delhi: The Subject Expert Committee (SEC) for Vaccines under the Central Drugs Standard Control Organisation (CDSCO) has recommended the conduct...
MSN Labs Gets SEC Nod to Conduct Phase III Trial of Semaglutide

MSN Labs Gets SEC Nod to Conduct Phase III Trial of Semaglutide

Dr. Divya Colin4 Jun 2025 3:10 PM IST
New Delhi: Reviewing the bioequivalence study of the antidiabetic drug Semaglutide of MSN Laboratories, the Subject Expert Committee (SEC) functional...
Eris Lifesciences

Revise Phase IV Protocol for Gliclazide-Sitagliptin FDC with Scientific Justification: SEC Tells Eris

Dr. Divya Colin4 Jun 2025 3:01 PM IST
New Delhi: Reviewing the Phase IV clinical trial of Eris Lifesciences' Fixed Dose Combination (FDC) antidiabetic drug Gliclazide plus Sitagliptin, the...
PrevNext

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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