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Tag: cdsco

You Searched For "cdsco"
Submit scientific justification for increasing patients number in study: CDSCO Tells Eli Lilly on Galcanezumab

Submit scientific justification for increasing patients number in study: CDSCO Tells Eli Lilly on Galcanezumab

Dr. Divya Colin3 Sept 2023 6:30 PM IST
New Delhi: In response to the proposal presented by the drug major Eli Lilly for the protocol amendment of the monoclonal antibody Galcanezumab, the...
Synokem Gets CDSCO Panel Nod to Study Antidiabetic FDC Drug Sitagliptin plus Empagliflozin

Synokem Gets CDSCO Panel Nod to Study Antidiabetic FDC Drug Sitagliptin plus Empagliflozin

Dr. Divya Colin3 Sept 2023 6:00 PM IST
New Delhi: The drug major Synokem Pharmaceuticals has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard...
USFDA nod to JnJ Tremfya for Crohns disease

Conduct Phase-III clinical trial in India: CDSCO panel tells Johnson and Johnson Over Guselkumab

Dr. Divya Colin2 Sept 2023 6:00 PM IST
New Delhi: Citing that there is no clinical data available on the Indian Population, the Subject Expert Committee (SEC) functional under the Central...
Health Bulletin 02/September/2023

Health Bulletin 02/September/2023

Isra Zaman2 Sept 2023 4:19 PM IST
Here are the Top health stories for the day:Death of pregnant doctor due to delayed medical attention: HC sets aside WBCERC order, directs...
Sun Pharma Gets CDSCO panel Nod To Manufacture, Market  Sitagliptin, Metformin, Glimepiride antidiabetic FDC

Sun Pharma Gets CDSCO panel Nod To Manufacture, Market Sitagliptin, Metformin, Glimepiride antidiabetic FDC

Dr. Divya Colin1 Sept 2023 6:00 PM IST
New Delhi: Based on the Phase III clinical trial report and bioequivalence (BE) study report of the antidiabetic fixed-dose combination (FDC) drug...
Synokem Gets CDSCO Panel Nod To Manufacture, Market antidiabetic FDC Pioglitazone, Vildagliptin

Synokem Gets CDSCO Panel Nod To Manufacture, Market antidiabetic FDC Pioglitazone, Vildagliptin

Dr. Divya Colin31 Aug 2023 6:00 PM IST
New Delhi: With the condition of conducting phase IV clinical trial, the Subject Expert Committee (SEC) functional under the Central Drug Standard...
Drug Alert: 51 Drug samples fail to qualify CDSCO test

Drug Alert: 51 Drug samples fail to qualify CDSCO test

Roshni Dhar31 Aug 2023 5:35 PM IST
In its latest drug alert, the apex drug regulatory body, the Central Drugs Standard Control Organization (CDSCO), has flagged 51 medicine batches for...
CDSCO Panel nod to MSN Labs Tolvaptan Tablets

submit pool data along with Indian patient data: CDSCO panel Tells MSN Laboratories Over Vigabatrin Tablets

Dr. Divya Colin30 Aug 2023 6:00 PM IST
New Delhi: In response to the proposal presented by the drug major MSN Laboratories to manufacture and market the antiepileptic drug Vigabatrin, the...
Sun Pharma, Philogen complete patient enrollment in Phase III trial for Soft Tissue Sarcoma

Sun Pharma Gets CDSCO Panel Nod to Manufacture, Market Antidiabetic FDC Drug

Dr. Divya Colin30 Aug 2023 6:00 PM IST
New Delhi: Pharmaceutical major, Sun Pharma Laboratories has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug...
Health Bulletin 30/August/2023

Health Bulletin 30/August/2023

Roshni Dhar30 Aug 2023 4:30 PM IST
Here are the top health stories for the day:NMC tells medical colleges, appellants to follow procedure for filing appeals, notifies on timeline,...
Submit interim analysis results of study in Russia and India: CDSCO panel Tells Lupin Over Aflibercept

Submit interim analysis results of study in Russia and India: CDSCO panel Tells Lupin Over Aflibercept

Dr. Divya Colin28 Aug 2023 6:00 PM IST
New Delhi: In response to the proposal to enroll an additional 298 patients from India in the study of the ophthalmic drug Aflibercept, the Subject...
Submit dose Justification and international standards data: CDSCO panel Tells Synokem over Sacubitril, valsartan FDC

Submit dose Justification and international standards data: CDSCO panel Tells Synokem over Sacubitril, valsartan FDC

Dr. Divya Colin27 Aug 2023 6:00 PM IST
New Delhi: In response to the clinical trial protocol for the drug combination of sacubitril and valsartan presented by the drug maker Synokem, the...
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