Expert Panel Rejects Zuventus' Trelagliptin PMS Plan, Seeks Higher Patient Enrolment Parthika Patel18 Aug 2025 2:37 PM ISTNew Delhi: Zuventus Healthcare Limited's proposal for the active post-marketing surveillance (PMS) study of Trelagliptin Tablets 25 mg, 50 mg and 100...
CDSCO Panel Accepts Glenmark's Apremilast Trial Report, Seeks 2-Year PSUR Data Parthika Patel10 Aug 2025 1:00 PM ISTNew Delhi: Glenmark Pharmaceuticals Limited has received approval from the Subject Expert Committee (SEC), functioning under the Central Drugs...
Intas Pharma Gets Expert Panel Nod For PMS Data On Tofacitinib Ointment In Atopic Dermatitis Parthika Patel9 Aug 2025 11:30 AM ISTNew Delhi: Intas Pharma has received approval from the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO)...
Expert Panel Approves Post-Marketing Surveillance Study of Eculizumab (Soliris) by AstraZeneca in India Dr. Divya Colin6 July 2025 3:00 PM ISTNew Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted approval to...
Fresenius Told to Submit Global Data for Calcium Chloride Infusion Approval Parthika Patel18 Jun 2025 4:36 PM ISTNew Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has asked Fresenius Medical Care India...
CDSCO Panel Seeks Revised Protocol for Green Signal's BCG Vaccine PMS Study Parthika Patel5 Jun 2025 10:45 AM ISTNew Delhi: The Subject Expert Committee (SEC) on Vaccines, operating under the Central Drugs Standard Control Organization (CDSCO), has reviewed the...
Fresenius Told To Submit Approval Basis, Phase III Data for Calcium Chloride Dihydrate Infusion Proposal Dr. Divya Colin1 Jun 2025 4:30 PM ISTNew Delhi: In response to the proposal presented by Fresenius Medical Care, the Subject Expert Committee (SEC) functional under the Central Drug...
Akum Drugs Gets CDSCO Panel Nod To Conduct Post Marketing Surveillance study of Linezolid Sustained Release Tablets Dr. Divya Colin8 April 2025 5:45 PM ISTNew Delhi: Akums Drugs and Pharmaceuticals has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Generate PMS data to assess patient safety : CDSCO Panel Tells Novartis Healthcare on additional indications of Secukinumab Dr. Divya Colin17 March 2025 6:00 PM ISTNew Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the drug major...
Submit post-marketing safety data of Belumosudil in Chronic graft versus host disease: CDSCO Panel Tells Sanofi Dr. Divya Colin21 April 2024 6:00 PM ISTNew Delhi: Responding to the proposal presented by the drug major Sanofi to import and market Belumosudil tablets 200 mg, the Subject Expert Committee...
Zydus Healthcare Gets CDSCO Nod to study Fluticasone Furoate plus Vilanterol Trifenatate FDC Dr. Divya Colin22 Jan 2024 6:00 PM ISTNew Delhi: The drug major Zydus Healthcare has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
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...
