Need More Justification: CDSCO Panel rejects J&J protocol amendment proposal for Teclistamab study Dr. Divya Colin17 March 2024 5:45 PM ISTNew Delhi: Citing that more justification is required, the Subject Expert Committee SEC functional under the Central Drug Standard Control...
Glenmark Gets CDSCO Panel Nod to Study ISB 2001 in Multiple Myeloma Dr. Divya Colin28 Feb 2024 6:00 PM ISTNew Delhi: The drug major Glenmark has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Intas Pharma Gets CDSCO Panel Nod to Study anti-cancer Drug Lipid Based Cabazitaxel Dr. Divya Colin1 Feb 2024 6:00 PM ISTNew Delhi: Citing that the firm should include an adequate number of government hospital trial sites, the Subject Expert Committee (SEC) functional...
CDSCO Panel grants Bristol Myer Squibb's Proposal for Additional Indication of anti-cancer drug Nivolumab Dr. Divya Colin30 Jan 2024 5:30 PM ISTNew Delhi: Noting that sufficient safety data is established, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Determine efficacy of immunotherapy in PD-L1 negative and low patients: CDSCO Panel Tells Dr Reddy on Nivolumab Dr. Divya Colin20 Jan 2024 5:30 PM ISTNew Delhi: Based on the Phase I/III clinical trial protocol of the anti-cancer drug Nivolumab presented by the drug major Dr Reddy Laboratories, the...
Recombinant L-Asparginase not approved in India, conduct CT to study: CDSCO Panel tells Gennova Biopharmaceutical Dr. Divya Colin14 Jan 2024 5:00 PM ISTNew Delhi: Highlighting that recombinant L-Asparginase is presently not approved in India, the Subject Expert Committee (SEC) functional under the...
CDSCO Panel grants J&J Protocol Amendment proposal to study anticancer drug Amivantamab and Lazertinib Dr. Divya Colin9 Jan 2024 5:45 PM ISTNew Delhi: Regarding the study of Amivantamab and Lazertinib in combination with platinum-based chemotherapy compared with platinum-based chemotherapy...
Roche Gets CDSCO Panel Nod to Study anti-cancer Drug Giredestrant for Breast Cancer Dr. Divya Colin7 Jan 2024 6:00 PM ISTNew Delhi: The drug major Roche has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
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 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...
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...
