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  • protocol amendment

Tag: protocol amendment

You Searched For "protocol amendment"
Indian Pharma Market Expands 8.4% in January, Dapagliflozin, Vonoprazan Among Top-Selling Drugs: IQVIA

CDSCO Panel Approves IQVIA RDS Protocol Amendment Proposal for Survodutide study

Dr. Divya Colin2 Oct 2024 6:00 PM IST
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the protocol...
GSK Blujepa bags USFDA nod for treatment of uUTIs in female adults, paediatric patients 12 years of age and older

CDSCO Panel grants GSK's Protocol Amendment Proposal To Study Belantamab mafodotin

Dr. Divya Colin1 Oct 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...
Alloy Therapeutics collaborates with Pfizer to develop new antibody discovery platform

CDSCO Panel Approves Pfizer's Protocol Amendment Proposal to Study Aztreonam and Avibactam

Dr. Divya Colin21 Sept 2024 5:45 PM IST
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the protocol...
CDSCO Panel Approves Fabrazyme Label Update, Asks Sanofi to Submit EMA Nod

CDSCO Panel Approves Sanofi's Protocol Amendment proposal for Fitusiran study

Dr. Divya Colin7 Sept 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...
Justify Sample Size Hike in FDC Trial of Zibotentan-Dapagliflozin, CDSCO Panel Tells AstraZeneca

CDSCO Panel Approves AstraZeneca's Protocol Amendment proposal for COPD drug Tozorakimab

Dr. Divya Colin5 Sept 2024 6:00 PM IST
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the clinical trial...
US tariffs on pharma sector would be counterproductive for Americans, says Wockhardt Chairman

CDSCO Panel Approves Wockhardt's Protocol Amendment Proposal for antimicrobial drug Cefepime plus Zidebactam

Dr. Divya Colin3 Sept 2024 5:00 PM IST
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved Wockhardt's...
AstraZeneca Imfinzi recommended for approval in EU for adults with muscle-invasive bladder cancer

50% of trial sites should be Govt sites, more subjects should be enrolled from Govt sites: CDSCO panel tells AstraZeneca on Baxdrostat study

Dr. Divya Colin15 Aug 2024 5:45 PM IST
New Delhi: In line with the drug major AstraZeneca's protocol amendment proposal to study the cardiovascular drug Baxdrostat, the Subject Expert...
Indian Pharma Market Expands 8.4% in January, Dapagliflozin, Vonoprazan Among Top-Selling Drugs: IQVIA

CDSCO Panel Approves IQVIA RDS's Protocol Amendment Proposal for Spesolimab study

Dr. Divya Colin11 Aug 2024 5:15 PM IST
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved IQVIA RDS's...
Eli Lilly Alzheimers drug rejected by EU regulator

CDSCO Panel Approves Eli Lilly's Protocol Amendment proposal to study Antidiabetic Drug Tirzepatide

Dr. Divya Colin4 Aug 2024 5:45 PM IST
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has approved the protocol...
CDSCO Panel Asks Novartis to Submit Revised Protocol, Dose Changes for Ianalumab Phase III Trial

CDSCO panel Approves Novartis Protocol Amendment proposal to study inclisiran

Dr. Divya Colin4 Aug 2024 5:00 PM IST
New Delhi: The Subject Expert Committee SEC functional under the Central Drug Standard Control Organization (CDSCO) has approved the drug major...
CagriSema demonstrates superior weight loss in adults with obesity, type 2 diabetes in REDEFINE 2 trial: Novo Nordisk

CDSCO Panel Approves Novo Nordisk's Protocol Amendment proposal to study Somapacitan

Dr. Divya Colin31 July 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 Novo...
Icotrokinra results show significant skin clearance in patients with difficult to treat scalp, genital psoriasis: JnJ

CDSCO Panel Approves Johnson and Johnson's Protocol Amendment Proposal to Study JNJ-77242113

Dr. Divya Colin19 July 2024 5:45 PM IST
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major...
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