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  • protocol amendment

Tag: protocol amendment

You Searched For "protocol amendment"
AstraZeneca Imfinzi-based perioperative regimen approved in EU for resectable non-small cell lung cancer

CDSCO Panel Grants AstraZeneca's Protocol Amendment Proposal for Anifrolumab

Dr. Divya Colin4 Jan 2024 5:00 PM IST
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation CDSO has approved the drug major's...
CDSCO panel Approves Pfizers Protocol Amendment Proposal for Anti-cancer Drug Elranatamab

CDSCO panel Approves Pfizer's Protocol Amendment Proposal for Anti-cancer Drug Elranatamab

Dr. Divya Colin2 Jan 2024 5:30 AM IST
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the protocol...
CDSCO Panel Approves Pfizers Proposal for protocol amendment of Marstacimab

CDSCO Panel Approves Pfizer's Proposal for protocol amendment of Marstacimab

Dr. Divya Colin1 Jan 2024 5:30 PM IST
New Delhi: The drug major Pfizer has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Novartis bolsters Neuroscience pipeline

CDSCO Panel Grants Novartis Protocol Amendment For Ofatumumab

Dr. Divya Colin31 Dec 2023 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...
AstraZeneca, Daiichi Sankyo voluntarily withdraws datopotamab deruxtecan application

CDSCO Panel grants AstraZeneca's Protocol Amendment Proposal for Sodium zirconium cyclosilicate

Dr. Divya Colin31 Dec 2023 5:00 PM IST
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the protocol...
Submit Justification and Rational: CDSCO Panel tells  Pfizer on protocol amendment proposal for Palbociclib

Submit Justification and Rational: CDSCO Panel tells Pfizer on protocol amendment proposal for Palbociclib

Dr. Divya Colin20 Dec 2023 6:25 PM IST
New Delhi: In response to the proposal presented by the drug major Pfizer for the protocol amendment, the Subject Expert Committee (SEC) functional...
USFDA grants priority review to Sanofi-Regeneron Dupixent for bullous pemphigoid

CDSCO Panel Approves Sanofi's Protocol Amendment Proposal for SAR443122

Dr. Divya Colin2 July 2023 5:30 PM IST
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has approved the protocol...
Roche bags USFDA nod for companion diagnostic to identify patients with HER2-ultralow metastatic breast cancer eligible for Enhertu

CDSCO Panel Approves Roche's Protocol Amendment Proposal to Study Polatuzumab Vedotin

Dr. Divya Colin2 July 2023 5:15 PM IST
New Delhi: The Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) has approved the protocol amendment...
Indian Pharma Market Expands 8.4% in January, Dapagliflozin, Vonoprazan Among Top-Selling Drugs: IQVIA

IQVIA gets CDSCO panel okay to reopen trial recruitment in the country for Evobrutinib

Dr. Divya Colin26 Oct 2022 1:30 PM IST
New Delhi: Approving IQVIA proposal to amend Phase III Clinical Trail protocol of Bruton's tyrosine kinase (BTK) inhibitor Evobrutinib, the Subject...
AstraZeneca anticancer drug Trastuzumab Deruxtecan protocol amendment proposal approved by CDSCO panel

AstraZeneca anticancer drug Trastuzumab Deruxtecan protocol amendment proposal approved by CDSCO panel

Roshni Dhar23 Aug 2022 6:30 PM IST
Based on the justification provided by the pharma major AstraZeneca, the Subject Expert Committee(SEC) functional under Central Drug Standard Control...
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