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Tag: sec

You Searched For "sec"
USFDA concludes inspection at Shilpa Medicare Raichur unit

Shilpa Medicare Gets CDSCO Panel Nod for Novel NAFLD Drug, Advances to Marketing Approval Stage

Farhat Nasim14 Feb 2025 2:04 PM IST
Raichur: Shilpa Medicare Limited, recently announced that its Investigational New Drug (IND), Nor-Ursodeoxycholic Acid Tablets (500 mg), has received...
AstraZeneca anticancer drug Trastuzumab Deruxtecan protocol amendment proposal approved by CDSCO panel

AstraZeneca anticancer drug Trastuzumab Deruxtecan protocol amendment proposal approved by CDSCO panel

Roshni Dhar23 Aug 2022 6:30 PM IST
Based on the justification provided by the pharma major AstraZeneca, the Subject Expert Committee(SEC) functional under Central Drug Standard Control...
CDSCO Panel approves Intas Ranibizumab for new indication: retinopathy of pre maturity in preterm infants

CDSCO Panel approves Intas Ranibizumab for new indication: retinopathy of pre maturity in preterm infants

Dr. Divya Colin12 Jun 2022 1:18 PM IST
New Delhi: Considering the fact that the target subjects are infants, the Subject Expert Committee (SEC) functional under Central Drug Standard...
CDSCO panel directs SII to submit safety and immunogenicity data for TB vaccine

CDSCO panel directs SII to submit safety and immunogenicity data for TB vaccine

Susmita Roy5 May 2022 7:10 PM IST
New Delhi: Rejecting the vaccine major Serum Inst. of India's proposal for emergency use authorization of rBCG vaccine for prevention of Tuberculosis...
Novo Nordisk bags CDSCO panel nod to study anti neoplastic drug Concizumab

Novo Nordisk bags CDSCO panel nod to study anti neoplastic drug Concizumab

Dr. Divya Colin24 April 2022 12:30 PM IST
New Delhi: In line with the drug major Novo-Nordisk's proposal for Phase IIIa clinical trial of antineoplastic drug Concizumab, the Subject Expert...
Laurus gets CDSCO panel nod to market anti retroviral FDC Tenofovir Alafenamide Fumarate,Lamivudine, Dolutegravir

Laurus gets CDSCO panel nod to market anti retroviral FDC Tenofovir Alafenamide Fumarate,Lamivudine, Dolutegravir

Dr. Divya Colin12 April 2022 7:29 PM IST
New Delhi: Pharmaceutical major, Laurus has got the go ahead from the Subject Expert Committee (SEC) of the Central Drug Standard Control Organization...
Sanofi gets CDSCO panel okay to market Quadrivalent Inactivated Influenza vaccine

Sanofi gets CDSCO panel okay to market Quadrivalent Inactivated Influenza vaccine

Dr. Divya Colin12 March 2022 1:47 PM IST
New Delhi: Pharma major, Sanofi has got the go-head from the Subject Expert Committee (SEC) of the Central Drug Standard Control Organization (CDSCO)...
GSK Nucala application for COPD accepted for review in China

Setback: GSK proposal to market Meningococcal group B Vaccine rejected by CDSCO panel

Dr. Divya Colin11 March 2022 5:08 PM IST
New Delhi: In the major setback to GSK, citing that the firm has not submitted any safety and immunogenicity data in Indian population, the Subject...
CDSCO SEC okays Covovax for 12-17 year-olds

CDSCO SEC okays Covovax for 12-17 year-olds

Medical Dialogues Bureau6 March 2022 5:06 PM IST
New Delhi: The Subject Expert Committee (SEC) has recommended granting emergency use authorisation (EUA) to Serum India of India's COVID-19 vaccine...
22/January/2022 Top Health Bulletin

22/January/2022 Top Health Bulletin

Roshni Dhar22 Jan 2022 6:13 PM IST
Here are todays top health storiesIndia reports 3.37 lakh new cases, Omicron tally rises to over 10,000Covid-19 continues to rise admist all measures...
Novartis gets CDSCO panel nod to study Alpelisib for early (prophylactic) and sustained improvement of hyperglycemia

Novartis gets CDSCO panel nod to study Alpelisib for early (prophylactic) and sustained improvement of hyperglycemia

Medical Dialogues Team9 Jan 2022 8:45 PM IST
New Delhi: Pharmaceutical major Novartis has got a conditional nod from the Subject Expert Committee (SEC) of the Central Drugs Standard Control...
Novartis gets CDSCO panel nod to study Ligelizumab in  treatment of chronic inducible urticaria

Novartis gets CDSCO panel nod to study Ligelizumab in treatment of chronic inducible urticaria

Medical Dialogues Team7 Jan 2022 2:21 PM IST
New Delhi: Pharma major Novartis has got a go ahead from the Subject Expert Committee (SEC) functional under the Central Drugs Standard Control...
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