Zydus Lifscience Gets CDSCO Panel Nod to Study Measles and Rubella Vaccine Written By Dr. Divya Colin15 Aug 2024 6:00 PM ISTNew Delhi: The drug major Zydus Lifscience has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Serum Institute of India Gets CDSCO Panel Nod To study Meningococcal Polysaccharide Conjugate Vaccine Freeze-Dried Written By Dr. Divya Colin14 Aug 2024 6:00 PM ISTNew Delhi: The vaccine major Serum Institute of India has got approval from the Subject Expert Committee (SEC) functional under the Central Drug...
Intas Pharmaceuticals Gets CDSCO Panel Nod to Study Vedolizumab for Ulcerative Colitis Written By Dr. Divya Colin13 Aug 2024 6:00 PM ISTNew Delhi: Intas Pharmaceuticals has got the go-ahead from the Subject Expert Committee ( SEC) functional under the Central Drug Standard Control...
Submit Immunogenicity Data: CDSCO Panel Tells Pfizer on Pneumococcal Polysaccharide Conjugate Vaccine study Written By Dr. Divya Colin12 Aug 2024 6:00 PM ISTNew Delhi: Reviewing the Phase III clinical trial report of the 20 valent Pneumococcal Conjugate Vaccine (20vPnC) presented by Pfizer, the Subject...
Sun Pharmaceutical Industry gets CDSCO Panel nod to study Fexuprazan HCL tablet for erosive esophagitis Written By Dr. Divya Colin11 Aug 2024 6:00 PM ISTNew Delhi: Responding to the proposal presented by the Sun Pharmaceutical Industry to manufacture and market the Fexuprazan Hydrochloride tablet, the...
Dr. Reddy's Lab gets CDSCO Panel nod to study Semeglutide injection Written By Dr. Divya Colin10 Aug 2024 6:00 PM ISTNew Delhi: In line with the bioequivalence study report of Semaglutide Injection 2mg/1.5ml (1.34mg/ml) and 4mg/3ml (1.34mg/ml) (Synthetic Origin)...
Pfizer Gets CDSCO Panel Nod for Active PMS Study of FDC Levonorgestrel Plus Ethinyloestradiol Tablets Written By Dr. Divya Colin9 Aug 2024 6:00 PM ISTNew Delhi: The drug major Pfizer has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
CDSCO announces waiver of local clinical trials in 5 drug categories that are approved in developed markets Ruchika Sharma8 Aug 2024 2:21 PM ISTNew Delhi: In a significant move to improve the accessibility of new drugs in India, the Central Drugs Standard Control Organization (CDSCO) has...
Pfizer gets CDSCO Panel nod to study Somatrogon Written By Dr. Divya Colin7 Aug 2024 6:00 PM ISTNew Delhi: The drug major Pfizer has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Drugs not yet marketed in India, Submit PSUR Data: CDSCO Panel Tells Novo Nordisk on Semaglutide injection Written By Dr. Divya Colin6 Aug 2024 6:00 PM ISTNew Delhi: Noting that proposed drug products Semaglutide Injection 0.25mg/0.5mg/1mg/1.7mg/2.4mg (Wegovy) and Semaglutide Injection...
Justify proposed dose and rationality: CDSCO Panel Tells Lupin on FDC Sacubitril plus Valsartan Written By Dr. Divya Colin5 Aug 2024 6:00 PM ISTNew Delhi: In response to the justification presented by the drug major Lupin on the rationality of the fixed-dose combination (FDC) cardiovascular...
Submit clinical study data conducted in adults: CDSCO Panel Tells Sanofi on atopic dermatitis drug Written By Dr. Divya Colin4 Aug 2024 6:00 PM ISTNew Delhi: Responding to the protocol amendment proposal for Amlitelimab study, the Subject Expert Committee (SEC) functional under the Central Drug...
