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Tag: cdsco

You Searched For "cdsco"
CDSCO Panel Approves Novartis Protocol Amendment Proposal For Multiple Sclerosis Drug Ofatumumab

CDSCO Panel Approves Novartis Protocol Amendment Proposal For Multiple Sclerosis Drug Ofatumumab

Dr. Divya Colin11 Feb 2024 6:00 PM IST
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major...
Boehringer Ingelheim gets USFDA priority review for Zongertinib for HER2 (ERBB2)-mutant advanced non-small cell lung cancer treatment

Study Safety and Efficacy of Tenecteplase 0.25 mg/kg in Acute Ischemic Stroke: CDSCO Panel Tells Boehringer Ingelheim

Dr. Divya Colin10 Feb 2024 6:00 PM IST
New Delhi: Rejecting the drug major Boehringer Ingelheim's request for waiver of the local clinical trial of Metalyse 25 mg (tenecteplase 0.25 mg/kg)...
Indiscreet prescribing of antibiotics is key contributor to microbial resistance nationwide: MoS Health

Indiscreet prescribing of antibiotics is key contributor to microbial resistance nationwide: MoS Health

Ruchika Sharma9 Feb 2024 8:36 PM IST
New Delhi: The Union Health Ministry has initiated several initiatives to promote judicious use of antimicrobials, as indiscreet prescribing of...
Lupin unveils pregnancy prevention drug Minzoya in US

Submit Animal Toxicity Study Report: CDSCO Panel Tells Lupin on Parkinsonism FDC drug

Dr. Divya Colin9 Feb 2024 6:00 PM IST
New Delhi: Noting that the proposed dose is higher than the approved dose, the Subject Expert Committee (SEC) functional under the Central Drug...
Roche launches Elecsys PRO-C3 test to improve precision in evaluating liver fibrosis severity

Conduct India-specific Trial: CDSCO Panel Tells Roche on Satralizumab to Treat neuromyelitisoptica spectrum disorders

Dr. Divya Colin8 Feb 2024 6:00 PM IST
New Delhi: With an aim to establish the safety and efficacy of the Monoclonal Antibody Satralizumab in Indian patients, the Subject Expert Committee...
bms cancer drug dasatinib

CDSCO Panel Grants Bristol-Myers Squibb's Protocol Amendment proposal for Mavacamten

Dr. Divya Colin7 Feb 2024 6:00 PM IST
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has approved the drug major...
Synokem gets CDSCO Panel nod to study FDC Torsemide plus Eplerenone film coated tablet

Synokem gets CDSCO Panel nod to study FDC Torsemide plus Eplerenone film coated tablet

Dr. Divya Colin6 Feb 2024 6:00 PM IST
New Delhi: Considering the bioequivalence (BE) report of the fixed-dose combination (FDC) Torsemide IP 10mg/ 20mg plus Eplerenone IP 25mg/25mg...
Intas Gets CDSCO Panel Nod for Pertuzumab

CDSCO Panel grants Intas Package Insert update for Pegfilgrastim solution for injection 6mg/0.6mL vial and PFS

Dr. Divya Colin5 Feb 2024 6:00 PM IST
New Delhi: The Subject Expert Committee (SEC) functional under the Center Drug Standard Control Organisation (CDSCO) has approved drug major Intas...
CDSCO Panel grants Novartis Protocol Amendment proposal for Remibrutinib study in Relapsing Multiple Sclerosis

CDSCO Panel grants Novartis Protocol Amendment proposal for Remibrutinib study in Relapsing Multiple Sclerosis

Dr. Divya Colin5 Feb 2024 5:30 PM IST
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major...
Windlass Biotech gets CDSCO Panel Nod To Manufacture, Market Ezetimibe plus Atorvastatin Calcium tablet

Windlass Biotech gets CDSCO Panel Nod To Manufacture, Market Ezetimibe plus Atorvastatin Calcium tablet

Dr. Divya Colin4 Feb 2024 6:00 PM IST
New Delhi: In response to the proposal presented by the drug major Windlas Biotech, the Subject Expert Committee (SEC) functional under the Central...
Roche launches Elecsys PRO-C3 test to improve precision in evaluating liver fibrosis severity

CDSCO Panel Approves Roche's Protocol Amendment Proposal for Anticancer Drug Giredestrant

Dr. Divya Colin4 Feb 2024 5:00 PM IST
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major...
Open to expand US manufacturing as tariff threat looms: Dr Reddys Labs

Add geographically distributed Govt sites: CDSCO Panel tells Dr Reddy's on antirheumatic drug Abatacept study

Dr. Divya Colin3 Feb 2024 6:00 PM IST
New Delhi: The drug major Dr Redyy's Laboratories has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard...
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