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  • CDSCO (Central Drugs...

CDSCO (Central Drugs Standard Control Organisation) News - Page 10

Biocon Gets USFDA Approval for Everolimus Oral Suspension in Pediatric, Adult TSC

Biocon Told to Submit Detailed Toxicity, SAE Data on Semaglutide Prefilled Pen After Animal Deaths

Susmita Roy21 Oct 2025 1:00 PM IST
New Delhi: The Subject Expert Committee (SEC), functioning under the Central Drugs Standard Control Organisation (CDSCO), has opined that Biocon...
Eli Lilly in Talks to Acquire Ventyx Biosciences in USD 1 Billion-Plus Deal

CDSCO Panel Clears Eli Lilly's Tirzepatide for Phase IV Clinical Trial in India

Susmita Roy21 Oct 2025 12:30 PM IST
New Delhi: The Subject Expert Committee (SEC), functioning under the Central Drugs Standard Control Organisation (CDSCO), has granted permission to...
CDSCO Panel Asks Pure and Cure Healthcare To Revise Phase III Protocol of Tapinarof Cream

CDSCO Panel Rejects Pure and Cure's Empagliflozin-Based FDC, Flags Risk of UTI, Genital Mycosis

Susmita Roy20 Oct 2025 5:44 PM IST
New Delhi: Citing that there is a concern of the risk of genital mycosis and urinary tract infection (UTI) with Empagliflozin, the Subject Expert...
Dr Reddys Labs secures European Commission approval for biosimilar to treat osteoporosis

Dr. Reddy's Labs Gets CDSCO Panel Nod to Manufacture, Market Semaglutide Injection

Susmita Roy20 Oct 2025 5:35 PM IST
New Delhi: In a major development for diabetes care in India, Dr. Reddy's Labs has got the go-ahead from the Subject Expert Committee (SEC) functional...
CDSCO Panel Seeks Revised Phase IV Trial Protocol for MSN Labs Nelarabine Injection

MSN Labs Gets SEC Nod for Roflumilast as Starting Dose in COPD Therapy

Parthika Patel19 Oct 2025 12:00 PM IST
New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) has recommended the grant of permission to...
Zydus

CDSCO Panel Flags Small Sample Size, Limited Scope, Asks Zydus to Rework Phase IV Letermovir Study

Parthika Patel18 Oct 2025 6:55 PM IST
New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) has directed Zydus Lifesciences Ltd to...
CDSCO Panel Directs Abbott to Incorporate New Safety, Follow-up Measures in Clarithromycin Study

CDSCO Panel Directs Abbott to Incorporate New Safety, Follow-up Measures in Clarithromycin Study

Parthika Patel17 Oct 2025 6:50 PM IST
New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) has directed Abbott Healthcare Pvt. Ltd to...
CDSCO Panel Seeks More Clinical Data from Regenix Drugs on rDNA-Based Insulin Injection

CDSCO Panel Seeks More Clinical Data from Regenix Drugs on rDNA-Based Insulin Injection

Susmita Roy16 Oct 2025 7:30 PM IST
New Delhi: The Subject Expert Committee (SEC), functional under the Central Drugs Standard Control Organisation (CDSCO), has asked Regenix Drugs Ltd...
CDSCO Panel Clears BDR Pharmas Abiraterone Oral Suspension, Seeks Phase IV Trial

CDSCO Panel Clears BDR Pharma's Abiraterone Oral Suspension, Seeks Phase IV Trial

Parthika Patel15 Oct 2025 4:30 PM IST
New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) has recommended approval for Abiraterone...
Alkem Labs Slapped Rs 2.34 Cr GST Demand in Goa

Alkem Labs Gets CDSCO Panel Nod for conducting Phase III study of Semaglutide tablet

Susmita Roy14 Oct 2025 5:23 PM IST
New Delhi: Alkem Laboratories has got the go-ahead from the Subject Expert Committee (SEC), functioning under the Central Drug Standard Control...
Reliance Life Sciences Gets CDSCO Panel Nod for Phase I/III Trial of Biosimilar Nivolumab

Reliance Life Sciences Gets CDSCO Panel Nod for Phase I/III Trial of Biosimilar Nivolumab

Parthika Patel14 Oct 2025 5:09 PM IST
New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) has granted approval to Reliance Life...
SEC Asks Enzene Biosciences to Revise Phase III Trial Protocol for Nivolumab Biosimilar

SEC Asks Enzene Biosciences to Revise Phase III Trial Protocol for Nivolumab Biosimilar

Parthika Patel12 Oct 2025 10:30 AM IST
New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) has asked Enzene Biosciences Ltd to revise...
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Acne On Chest, Back and Shoulders: Expert Insights with Dermatologist Dr Rajat Kandhari

Acne On Chest, Back and Shoulders: Expert Insights with Dermatologist Dr Rajat Kandhari

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

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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

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