AstraZeneca gets CDSCO panel Nod To study antihypertensive drug Baxdrostat Dr. Divya Colin9 Dec 2023 9:34 PM ISTNew Delhi: The drug major AstraZeneca has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Novartis Gets CDSCO Panel Nod to study Remibrutinib to treat chronic spontaneous urticaria Dr. Divya Colin8 Dec 2023 6:00 PM ISTNew Delhi: The drug major Novartis has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Conduct post marketing clinical study to generate safety data of Nerivio: CDSCO panel Tells Dr Reddy's Lab Dr. Divya Colin6 Dec 2023 6:00 PM ISTNew Delhi: Considering the drug major Dr. Reddys Laboratorie's proposal to import the Nerve Electrical Stimulator (Brand Name: Nerivio) intended for...
Akum Pharmaceutical Gets CDSCO Panel Nod to Manufacture, Market Azelnidipine, Metoprolol FDC tablet Dr. Divya Colin3 Dec 2023 6:00 PM ISTNew Delhi: The drug major Akum Pharmaceuticals has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard...
CDSCO Panel approves Roche's PMS Study Report of Rituximab with Glucocorticoids in Wegener's Granulomatosis Dr. Divya Colin3 Dec 2023 5:15 PM ISTNew Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved a post-marketing...
Include Ankle Brachial Index test to exclude peripheral artery disease: CDSCO Panel Tells Lupin on Denosumab PK/PD study Dr. Divya Colin2 Dec 2023 6:00 PM ISTNew Delhi: The drug major Lupin has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Dr. Reddy's Gets CDSCO Panel Nod to Study FDC Etoricoxib plus Thiocolchicoside for Export purpose Dr. Divya Colin1 Dec 2023 6:00 PM ISTNew Delhi: The drug major Dr Reddy's Laboratories has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard...
Submit Justification to study Tocilizumab in patients with giant cell arteritis: CDSCO Panel Tells Cipla Dr. Divya Colin30 Nov 2023 6:00 PM ISTNew Delhi: Reviewing the protocol presented by the drug major Cipla for the approval post-marketing active surveillance of Tocilizumab in patients of...
Conduct bioequivalence study: CDSCO Panel Tells Lupin on FDC Indacaterol, Glycopyrronium inhalation powder Dr. Divya Colin28 Nov 2023 6:00 PM ISTNew Delhi: Rejecting the justification for the waiver of the bioequivalence study (BE) and Phase III clinical study of fixed-dose combination (FDC)...
Modify phase IV CT Protocol: CDSCO panel Tells Akums Pharma on FDC Bempedoic acid, Rosuvastatin Calcium Dr. Divya Colin26 Nov 2023 5:45 PM ISTNew Delhi: After reviewing the Phase IV clinical trial protocol of the fixed-dose combination Bempedoic acid plus Rosuvastatin Calcium presented by...
Exemed Pharmaceuticals gets CDSCO panel Nod To Manufacture, Market Antidiabetic Drug Imeglimin HCl SR Tablets Dr. Divya Colin26 Nov 2023 5:45 PM ISTNew Delhi: Based on the bioequivalence study report and Phase III clinical trial report of the antidiabetic drug Imeglimin hydrochloride presented by...
Torrent Pharma gets CDSCO Panel nod to study Brexpiprazole tablet to treat schizophrenia Dr. Divya Colin26 Nov 2023 5:00 PM ISTNew Delhi: Citing that the clinical trial sites should be geographically distributed in the country, the Subject Expert Committee (SEC) functional...
