Insufficient CT data in female population: CDSCO Panel tells Alkem Laboratories on Relugolix Tablets Dr. Divya Colin31 July 2024 6:00 PM ISTNew Delhi: Noting insufficient clinical trial data in the female population for applied indication, the Subject Expert Committee (SEC) functional...
Akums Drugs and Pharmaceuticals Gets CDSCO Panel Nod To study Norethindrone, Estradiol, Relugolix FDC Dr. Divya Colin30 July 2024 6:00 PM ISTNew Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted approval to the drug...
Drug Safety Alert: Indian Pharmacopoeia Commission Flags ADR Linked To Vancomycin Susmita Roy29 July 2024 6:00 PM ISTNew Delhi: The Indian Pharmacopoeia Commission (IPC), through its recently issued drug safety alert for the month of July, has revealed that...
Novartis Healthcare Gets CDSCO Panel Nod to Study Asciminib Filmcoated Tablets Dr. Divya Colin28 July 2024 6:00 PM ISTNew Delhi: Suggesting to add more government sites, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization...
Zydus Life Sciences Gets CDSCO Panel Nod to Study anti-cancer drug Relugolix Dr. Divya Colin27 July 2024 6:00 PM ISTNew Delhi: The drug major Zydus Lifscience has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
GSK Pharma India Gets CDSCO Panel Nod for phase 3 CT of Belrestotug and Dostarlimab Dr. Divya Colin26 July 2024 6:00 PM ISTNew Delhi: The drug major GSK Pharma India has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard...
Submit AE and SAE Data : CDSCO Panel Tells MSN Pharmaceuticals on Anti-cancer Drug MK-1084 Dr. Divya Colin25 July 2024 6:00 PM ISTNew Delhi: Reviewing phase 3 clinical study protocol of the anti-cancer drug MK-1084, the Subject Expert Committee (SEC) functional under the Central...
30 Formulations declared Not of Standard Quality as per data provided by states: CDSCO Drug Alert Dr. Divya Colin24 July 2024 6:00 PM ISTNew Delhi: In line with the 'Not of Standard Quality' data provided by states, the apex drug regulatory body, the Central Drug Standard Control...
Submit complete Phase-I CT report: CDSCO Panel Tells Biological E on Bivalent Typhoid and Paratyphoid A Conjugate Vaccine Dr. Divya Colin23 July 2024 6:00 PM ISTNew Delhi: Reviewing the interim Phase-I clinical trial report of Typhoid and Paratyphoid A Conjugate Vaccine Bivalent, the Subject Expert Committee...
CDCSO Declares 31 Formulations As Not of Standard Quality: Details Dr. Divya Colin22 July 2024 6:00 PM ISTNew Delhi: In its latest drug safety alert, the apex drug regulatory body, the Central Drug Standard Control Organisation (CDSCO), has flagged 31...
Conduct Phase III CT: CDSCO Panel Tells BDR Pharmaceuticals on Linaclotide Capsules Dr. Divya Colin21 July 2024 6:00 PM ISTNew Delhi: Granting a waiver of the bioequivalence (BE) study, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Submit data on prevalence and genetic polymorphism of disease: CDSCO Panel Tells Dr Reddy's Laboratories on Siponimod tablet Dr. Divya Colin20 July 2024 6:00 PM ISTNew Delhi:In response to the proposal presented by the drug major Dr Reddy's Laboratories to manufacture and market the neurodrug Siponimod tablets...
