Do not prescribe Pholcodine-containing cough syrup:DCGI tells Doctors Susmita Roy21 July 2023 6:49 PM ISTAccording to the advisory doctors and healthcare professionals should advise patients to stop taking Pholcodine containing cough and cold remedies and...
MSN Laboratories Gets CDSCO Panel Nod To Manufacture, Market Selexipag for Injection Dr. Divya Colin20 July 2023 6:00 PM ISTNew Delhi: The drug major MSN Laboratories has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard...
Submit Revised protocol for Torsemide ER tablets: CDSCO Tells Syngene Dr. Divya Colin19 July 2023 6:00 PM ISTNew Delhi: Highlighting that proof of concept and criteria are not defined for the overactive bladder in Congestive heart failure (CHF) patients, the...
Submit Revise Protocol for TIN-816 : CDSCO panel Tells Novartis Dr. Divya Colin18 July 2023 6:00 PM ISTNew Delhi: In response to the proposal to conduct the Phase IIa clinical trial of TIN-816 presented by the drug major Novartis, the Subject Expert...
Hetero Labs Gets CDSCO Panel Nod To Study Antibiotic Tebipenem Pivoxil Dispersible Tablet Dr. Divya Colin17 July 2023 6:00 PM ISTNew Delhi: Stating that the decision to waive off the clinical trial will be taken after a review of the Bioequivalence study report, the Subject...
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...
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...
