Glenmark gets CDSCO panel nod to manufacture ,market pulmonary FDC drug Dr. Divya Colin10 April 2023 6:00 PM ISTNew Delhi: The drug major Glenmark has got the go ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
CDSCO panel grants approval to Akums for PK study of pulmonary FDC Dr. Divya Colin10 April 2023 6:00 PM ISTNew Delhi: Citing that the pharmacokinetic study should be presented before the committee for review, the Subject Expert Committee (SEC) functional...
CDSCO panel approves Reliance Life Science's Phase III CT Protocol for Tocilizumab Dr. Divya Colin9 April 2023 5:55 PM ISTNew Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has approved Reliance Life...
Sun Pharma gets CDSCO panel nod to study COPD drug combination Dr. Divya Colin6 April 2023 6:00 PM ISTNew Delhi: Pharmaceutical major, Sun Pharma has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard...
CDSCO Drug Alert: 59 Drug Samples Including Sun Pharma's Montek LC, Alkem's Pan 40, Glenmark's Telma 40 Flagged Dr. Divya Colin2 April 2023 6:00 PM ISTNew Delhi: In its latest drug safety alert, the apex drug regulatory body, Central Drugs Standard Control Organization (CDSCO) has flagged 59 medicine...
Conduct PK study for repeated dose and Phase III CT : CDSCO Panel tells Sun Pharma on Psoriatic drug combination Dr. Divya Colin1 April 2023 6:00 PM ISTNew Delhi: Rejecting the drug major Sun Pharma's proposal for a Phase III clinical trial study waiver, the Subject Expert Committee (SEC) functional...
Include Tramadol associated Hiccups In Patient Information Leaflet: CDSCO Panel Susmita Roy30 March 2023 6:00 PM ISTNew Delhi: The Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organization (CDSCO) has issued recommendations...
Diabetes drug: Sanofi gets marketing authorization from CDSCO for Soliqua Ruchika Sharma28 March 2023 3:14 PM ISTSoliqua (10-40 and 30-60 prefilled pens) is a once-daily injectable combination drug containing insulin glargine 100 Units/ml, which is a long-acting...
Revise CT protocol: CDSCO Panel tells Intas on antipsychotic Drug Endoxifen Dr. Divya Colin27 March 2023 6:00 PM ISTNew Delhi: Noting that the study drug Endoxifen is already approved in India since 10-12-2019 for proposed indication, the Subject Expert Committtee...
Emcure, MSD get CDSCO Panel conditional nod to Manufacture, Market HIV drug Doravirine Dr. Divya Colin26 March 2023 6:00 PM ISTNew Delhi: Citing the unmet need, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has...
Syngene Proposal To Conduct Phase I CT of Ferumoxytol Inj rejected by CDSCO panel Dr. Divya Colin26 March 2023 5:30 PM ISTNew Delhi: Stating that the proposal submitted by Syngene International could not be considered at present, the Subject Expert Committee (SEC)...
All SAEs including death should be reported: CDSCO Panel tells AstraZeneca about Durvalumab Dr. Divya Colin25 March 2023 6:00 PM ISTNew Delhi: Granting the protocol amendment proposal presented by drug major AstraZeneca for anticancer drug Durvalumab, the Subject Expert Committee...
