Cipla Gets CDSCO Panel Nod To import, market Human Insulin inhalation powder with inhaler Dr. Divya Colin31 March 2024 5:00 PM ISTNew Delhi: Pharmaceutical major Cipla has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
CT waiver not considered, Conduct BA study: CDSCO Panel Tells Sun Pharma on Pulmonary FDC Dr. Divya Colin30 March 2024 6:00 PM ISTNew Delhi: Denying to consider the clinical trial waiver proposal for the fixed dose combination (FDC) Vilanterol Trifenatate plus Umeclidinium...
AstraZeneca India bags dual CDSCO nod for Trastuzumab deruxtecan Ruchika Sharma28 March 2024 1:30 PM ISTBangalore: AstraZeneca Pharma India Limited has received permission to import for sale and distribution of Trastuzumab deruxtecan lyophilized...
Sanofi Gets CDSCO Panel Nod To Import, Market Nirsevimab to Treat Respiratory Syncytial Virus Disease Dr. Divya Colin27 March 2024 6:00 PM ISTNew Delhi: Pharmaceutical major Sanofi Healthcare India has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug...
CDSCO Panel Approves IQVIA's Protocol Amendment Proposal For Anti-cancer Drug Xevinapant Dr. Divya Colin27 March 2024 5:30 AM ISTNew Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major...
Submit Current Safety Data of Indians: CDSCO Panel Tells Glenmark on anti-cancer drug ISB1442 Dr. Divya Colin26 March 2024 6:00 PM ISTNew Delhi: Reviewing the Phase I/II clinical study protocol of the anti-cancer drug ISB1442 presented by the drug major Glenmark, the Subject Expert...
Recalculate sample size based on serious adverse event: CDSCO Panel Tells Roche on Polatuzumab vedotin study Dr. Divya Colin25 March 2024 6:00 PM ISTNew Delhi: In line with the Phase IV clinical trial protocol of Polatuzumab Vedotin for Injection, 30mg/vial and 140 mg/vial, the Subject Expert...
CDSCO Panel Approves AstraZeneca's Protocol Amendment Proposal For Anti-cancer Drug Osimertinib Dr. Divya Colin25 March 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...
Modify CT Protocol: CDSCO Panel Tells GSK on Respiratory Syncytial Virus(RSV) Vaccine Dr. Divya Colin24 March 2024 6:00 PM ISTNew Delhi: Reviewing the Phase III clinical trial protocol presented by the drug major GSK for the Respiratory Syncytial Virus (RSV) vaccine...
Pfizer Gets CDSCO Panel Nod To study anti-cancer drug Lorlatinib Dr. Divya Colin24 March 2024 5:45 PM ISTNew Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major...
Conduct bioequivalence study: CDSCO Panel Tells Emcure Pharmaceutical on Ferric Maltol Capsules Dr. Divya Colin23 March 2024 6:00 PM ISTNew Delhi: Citing there is an unmet medical need, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation...
Submit Periodic Safety Update Report In Indian Population: CDSCO Panel Tells Intas on rHumanErythropoeitinalfa injection Dr. Divya Colin22 March 2024 6:00 PM ISTNew Delhi: Reviewing the proposal presented by the drug major Intas Pharmaceuticals for the revision in package insertion of rh-EPO (r Human...
