Dr Reddy's Gets CDSCO Panel Nod To Import, Market Saccharomyces Boulardii, BE, CT Waived Dr. Divya Colin15 Jun 2025 12:30 PM ISTNew Delhi: Granting the bioequivalence study waiver and clinical trial study waiver, the Subject Expert Committee (SEC) functional under the Central...
SEC Asks Abbott to Submit More Data on Vitamin C Plus D3 FDC Chewable Tablet, Cites Lack of Justification Dr. Divya Colin14 Jun 2025 6:19 PM ISTNew Delhi: In response to the proposal presented by Abbott, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
CDSCO Panel Approves Updated Prescribing Information for AstraZeneca's Rosuvastatin (Crestor) Dr. Divya Colin8 Jun 2025 12:43 PM ISTNew Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has granted approval for the updated...
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...
CDSCO Panel Recommends Phase III Trial of Tetanus Vaccine by Indian Immunologicals in Pregnant Women Parthika Patel4 Jun 2025 3:33 PM ISTNew Delhi: The Subject Expert Committee (SEC) for Vaccines under the Central Drugs Standard Control Organisation (CDSCO) has recommended the conduct...
MSN Labs Gets SEC Nod to Conduct Phase III Trial of Semaglutide Dr. Divya Colin4 Jun 2025 3:10 PM ISTNew Delhi: Reviewing the bioequivalence study of the antidiabetic drug Semaglutide of MSN Laboratories, the Subject Expert Committee (SEC) functional...
Revise Phase IV Protocol for Gliclazide-Sitagliptin FDC with Scientific Justification: SEC Tells Eris Dr. Divya Colin4 Jun 2025 3:01 PM ISTNew Delhi: Reviewing the Phase IV clinical trial of Eris Lifesciences' Fixed Dose Combination (FDC) antidiabetic drug Gliclazide plus Sitagliptin, the...
Cipla Gets CDSCO Panel Nod To BE Study, Phase III Trial of Semaglutide for Weight Management Dr. Divya Colin4 Jun 2025 2:52 PM ISTNew Delhi: Drug major Cipla has received approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
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...
CDSCO Panel Asks Novartis to Submit Revised Protocol, Dose Changes for Ianalumab Phase III Trial Dr. Divya Colin1 Jun 2025 4:00 PM ISTNew Delhi: Reviewing the Phase III clinical of the Ianalumab (VAY736) presented by Novartis, the Subject Expert Committee (SEC) functional under the...
CDSCO Panel Clears Sanofi's Updated Myozyme Insert, Seeks Revision on Administration Guidance Dr. Divya Colin30 May 2025 7:15 PM ISTNew Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has recommended the approval of the...
Shilpa Medicare Gets CDSCO Panel Nod for Novel NAFLD Drug, Advances to Marketing Approval Stage Farhat Nasim14 Feb 2025 2:04 PM ISTRaichur: Shilpa Medicare Limited, recently announced that its Investigational New Drug (IND), Nor-Ursodeoxycholic Acid Tablets (500 mg), has received...
