CDSCO Panel Rejects Morepen Laboratories' Proposal To Waive local Phase III clinical trial of Resmetirom Tablet Dr. Divya Colin18 May 2025 6:00 PM ISTNew Delhi: Rejecting the proposal for the local Phase III clinical trial waiver, the Subject Expert Committee (SEC) functional under the Central Drug...
MSN Laboratories Gets CDSCO Panel Nod To study Brexpiprazole Tablets Dr. Divya Colin2 May 2025 6:00 PM ISTNew Delhi: Considering the bioequivalence study of Brexpiprazole Tablets 0.25mg /0.5 mg/1mg/2mg/3mg/4mg, the Subject Expert Committee (SEC) functional...
Cipla gets CDSCO Panel nod to study Revefenacin Inhalation solution Susmita Roy20 April 2025 6:00 PM ISTNew Delhi: The pharmaceutical major Cipla has got the go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard...
CDSCO Panel suggests revising phase III CT protocol of Zydus Healthcare's Empagliflozin plus Metoprolol Succinate FDC Dr. Divya Colin15 March 2025 6:00 PM ISTNew Delhi: Considering the bioequivalence (BE) study report presented by Zydus Healthcare for the fixed dose combination of empagliflozin plus...
Abbott India Gets CDSCO Panel Nod To Conduct Phase III CT of Ursodeoxycholic Acid tablet Dr. Divya Colin6 Jan 2025 6:00 PM ISTNew Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted approval to the drug...
CDSCO Panel rejects Zydus Healthcare's proposal to waive Phase III CT of Diphenhydramine, Phenylephrine FDC Dr. Divya Colin30 Dec 2024 5:45 PM ISTNew Delhi: Denying the proposal for a phase III clinical trial (CT) waiver, the Subject Expert Committee (SEC) functional under the Central Drug...
Intas Pharmaceuticals Gets CDSCO Panel Nod to Study R-hFSH Solution for Injection Dr. Divya Colin10 Nov 2024 6:00 PM ISTNew Delhi: Intas Pharmaceuticals has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Intas Pharmaceutical Gets CDSCO Panels Nod to Conduct Phase III clinical trial of Ruxolitinib cream Dr. Divya Colin3 Nov 2024 5:00 PM ISTNew Delhi: Intas Pharmaceutical has got the go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
AstraZeneca gets CDSCO Panel nod to study Budesonide, Glycopyrronium and Formoterol Fumarate Dr. Divya Colin20 Oct 2024 5:45 PM ISTNew Delhi: The drug major AstraZeneca has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Dr. Reddy's Lab gets CDSCO Panel nod to study Semeglutide injection 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)...
Eli Lilly Gets CDSCO Panel Nod to Study Retatrutide Dr. Divya Colin1 Aug 2024 6:00 PM ISTNew Delhi: Pharmaceutical major Eli Lilly has got the go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard...
Submit AE and SAE Data : CDSCO Panel Tells MSN Pharmaceuticals on Anti-cancer Drug MK-1084 Dr. Divya Colin25 July 2024 6:00 PM ISTNew Delhi: Reviewing phase 3 clinical study protocol of the anti-cancer drug MK-1084, the Subject Expert Committee (SEC) functional under the Central...
