Justify inter-subject variability in BE study data: CDSCO Panel Tells Alkem on anticancer drug Relugolix Dr. Divya Colin7 Jan 2024 5:30 PM ISTNew Delhi: Reviewing the bioequivalence (BE) study report of the anti-cancer drug Relugolix presented by the drug major Alkem Laboratories, the...
CDSCO Panel Grants Novartis Protocol Amendment Proposal For Alpelisib Dr. Divya Colin7 Jan 2024 5:00 PM ISTNew Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major...
Submit PK-PD data of 3 cohorts for 7 days: CDSCO Panel Tells Shilpa Medicare on Ondansetron ER Inj Suspension IM study Dr. Divya Colin6 Jan 2024 5:30 PM ISTNew Delhi: Regarding the conduction of a study to evaluate the efficacy and safety of Ondansetron Extended-Release Injectable Suspension Intramuscular...
AstraZeneca Gets CDSCO Panel Nod to Study anti-cancer drug Dato-DXd and Durvalumab Dr. Divya Colin5 Jan 2024 6:00 PM ISTNew Delhi: The drug major AstraZeneca has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Submit Separate Toxicity Data on Indian Subject: CDSCO Panel Tells GSK on BelantamabMafodotin study Dr. Divya Colin4 Jan 2024 6:00 PM ISTNew Delhi: Considering the serious adverse events in the study data (phase-I & II) of Belantamab Mafodotin (GSK2857916) for Injection 100mg...
CDSCO Panel Grants AstraZeneca's Protocol Amendment Proposal for Anifrolumab Dr. Divya Colin4 Jan 2024 5:00 PM ISTNew Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation CDSO has approved the drug major's...
AstraZeneca Gets CDSCO Panel Nod to Study anticancer drug Volrustomig Dr. Divya Colin3 Jan 2024 6:00 PM ISTNew Delhi: The drug major AstraZeneca has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Sun Pharma gets CDSCO Panel Nod To Manufacture and market antianxiety drug Etifoxine HCl Capsule Dr. Divya Colin2 Jan 2024 6:00 PM ISTNew Delhi: Pharmaceutical major, Sun Pharma has got the go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard...
CDSCO panel Approves Pfizer's Protocol Amendment Proposal for Anti-cancer Drug Elranatamab Dr. Divya Colin2 Jan 2024 5:30 AM ISTNew Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the protocol...
CDSCO Panel Approves AstraZeneca's Proposal for Protocol Amendment of anti-cancer drug Asciminib Dr. Divya Colin2 Jan 2024 5:30 AM ISTNew Delhi: The drug major Novartis has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Justify Clinical Relevance of Higher Strength of Caroverine Capsules: CDSCO Panel Tells Lincoln Pharma Dr. Divya Colin1 Jan 2024 5:30 PM ISTNew Delhi: Noting that proposed higher strength of Caroverine Capsules (40mg) is not approved anywhere in the world, the Subject Expert Committee...
CDSCO Panel Approves Pfizer's Proposal for protocol amendment of Marstacimab Dr. Divya Colin1 Jan 2024 5:30 PM ISTNew Delhi: The drug major Pfizer has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
