CDSCO Panel Approves BE Study for Alkem's Dapagliflozin, Pioglitazone, Metformin FDC, Seeks Revised Phase III Plan Dr. Divya Colin2 Jun 2025 1:51 PM ISTNew Delhi: Alkem Laboratories has received approval from the Subject Expert Committee (SEC) under the Central Drug Standard Control Organisation...
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...
Don't throw in the bin, please flush it! CDSCO dictum for these 17 medicines Farhat Nasim31 May 2025 6:21 PM ISTNew Delhi: In a move to streamline the disposal of expired or unused medicines, the Central Drugs Standard Control Organisation (CDSCO) has issued a...
Justify Sample Size Hike in FDC Trial of Zibotentan-Dapagliflozin, CDSCO Panel Tells AstraZeneca Dr. Divya Colin31 May 2025 6:04 PM ISTNew Delhi: Reviewing the amendment protocol of the AstraZeneca's fixed dose combination (FDC) Zibotentan plus Dapagliflozin, the Subject Expert...
Bayer Gets CDSCO Panel Nod To Conduct Phase 3 Trial for Finerenone Dr. Divya Colin31 May 2025 5:56 PM ISTNew Delhi: Bayer Pharmaceutical has received approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Dr Reddy's Gets SEC Nod for Higher Semaglutide Dose in Ongoing Phase III Study, Govt Sites Mandated Dr. Divya Colin30 May 2025 8:14 PM ISTNew Delhi: In response to the proposal presented by the Dr Reddy's Laboratories, the Subject Expert Committee (SEC) functional under the Central Drug...
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...
CDSCO Committee Recommends SpinoS to Conduct BE Study with Vitamin D Screening Conditions Dr. Divya Colin30 May 2025 1:00 PM ISTNew Delhi: The SpinoS Lifescience And Research has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard...
Only Licensed Importers Can Overprint Labels Under Rule 104A, Clarifies CDSCO Dr. Divya Colin29 May 2025 8:05 PM ISTNew Delhi: The Central Drugs Standard Control Organisation (CDSCO) has clarified that overprinting or stickering of drug products under the Drugs...
Expert Panel Tells IPCA to Revise Hydroxychloroquine Phase III Trial for Diabetes Dr. Divya Colin28 May 2025 11:35 PM ISTNew Delhi: In response to the proposal presented by IPCA Laboratories Limited, the Subject Expert Committee (SEC) functional under the Central Drug...
CDSCO Panel Accepts BE Report, Tells Intas Pharma to Conduct Phase III Trial for Semaglutide Dr. Divya Colin28 May 2025 3:00 PM ISTNew Delhi: In response to a proposal submitted by Intas Pharmaceuticals, the Subject Expert Committee (SEC) under the Central Drugs Standard Control...
