Submit additional data: CDSCO Tells Laurus Labs to on Carglumic acid dispersible tablets Dr. Divya Colin17 July 2023 5:00 PM ISTNew Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has recommended the drug major...
Serum Institute of India Gets CDSCO Panel Nod for Phase III CT of Inactivated Salk Polio Vaccine Dr. Divya Colin16 July 2023 6:00 PM ISTNew Delhi: Based on the interim report of the Phase II clinical trial of the Inactivated Salk Polio Vaccine (Adsorbed) presented by vaccine maker...
Conduct bioequivalence Study of Elagolix tablets: CDSCO panel tells Hetero Labs Dr. Divya Colin16 July 2023 5:30 PM ISTNew Delhi: In response to the proposal presented by the drug major Hetero Labs to manufacture and market Elagolix tablet 150mg and 200mg, the Subject...
Novartis gets CDSCO Panel Nod To Import, Market Inclisiran solution for injection Dr. Divya Colin15 July 2023 6:00 PM ISTNew Delhi: After deliberating the interim data of a Phase-III global clinical trial of Inclisiran solution for injection presented by pharmaceutical...
Design protocol as Phase III CT for 1 to more than 50 years age group: CDSCO panel tells Bharat Biotech on JE vaccine Dr. Divya Colin14 July 2023 6:00 PM ISTNew Delhi: In response to the proposal presented by the vaccine maker Bharath Biotech to conduct the Phase IV clinical trial of the Japanese...
Conduct Phase III CT: CDSCO Panel Tells Biocon Biologics Over Anti-cancer Drug Nimutuzumab Dr. Divya Colin13 July 2023 6:00 PM ISTNew Delhi: Observing that there is no convincing data available for the proposed additional indication for the drug Nimutuzumab, the Subject Expert...
GSK gets CDSCO panel Nod for Phase III Extension safety follow-up study for trial of RSVPreF3 vaccine Dr. Divya Colin12 July 2023 6:00 PM ISTNew Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has granted approval to the drug...
More clinical trial sites should be included: CDSCO Panel tells Akum Pharma over Letrozole tablet Dr. Divya Colin11 July 2023 6:00 PM ISTNew Delhi: Noting more clinical trial sites should be included to have geographically distributed sites across India, the Subject Expert Committee...
Revise CT Protocol: CDSCO Panel Tells Roche on Ophthalmic Drug RO7200220 Dr. Divya Colin10 July 2023 6:00 PM ISTNew Delhi: Responding to the drug major Roche's proposal to conduct a Phase III clinical trial of RO7200220, anti-interleukin-6 (IL-6), the Subject...
Akums Pharma Gets CDSCO Panel Nod To Manufacture, Market Antidiabetic FDC Drug Dr. Divya Colin9 July 2023 6:00 PM ISTNew Delhi: Noting that the antidiabetic fixed-dose combination (FDC), Sitagliptin Phosphate Monohydrate 100mg/100mg plus Pioglitazone 15mg/15mg plus...
Ajanta Pharma Gets CDSCO Panel Nod To Manufacture, Market Tadalafil Oral Jelly for Erectile Dysfunction Dr. Divya Colin9 July 2023 5:30 PM ISTNew Delhi: Granting the clinical trial study waiver, the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization...
Akums Pharma Gets CDSCO Panel Nod To Manufacture, Market Tamsulosin HCL, Tadalafil FDC Tablet Dr. Divya Colin8 July 2023 6:00 PM ISTNew Delhi: The drug major Akums Drugs and Pharmaceuticals has got the go-ahead from the Subject Expert Committee (SEC) functional under the Central...
