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...
Prices Of Essential Medicines To Rise Slightly From April 1 Dr. Divya Colin29 March 2024 6:00 PM ISTNew Delhi: A slight hike in the price of essential medicines, such as painkillers, antibiotics, and anti-infectives, is set to take place on April...
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...
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...
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...
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...
Pfizer Gets CDSCO Panel Nod to Study Anti-cancer Drug PF-07220060 Dr. Divya Colin21 March 2024 6:00 PM ISTNew Delhi: The drug major Pfizer has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Submit Interim Safety, Efficacy Data: CDSCO Panel Tells Novartis on Crizanlizumab Dr. Divya Colin20 March 2024 6:00 PM ISTNew Delhi: Reviewing the status of the ongoing studies of Crizanlizumab concentrate for solution for infusion 10mg/mL (100mg/10mL), the Subject Expert...
