AstraZeneca's Proposal to Increase Sample Size in Zibotentan-Dapagliflozin Global Trial Gets SEC Nod Parthika Patel14 Sept 2025 3:00 PM ISTNew Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has recommended approval of a protocol...
CDSCO Panel Nod To Phase I Clinical Trial of Anticancer Drug Bevacizumab by Jeevan Scientific Susmita Roy14 Sept 2025 11:30 AM ISTNew Delhi: Noting that the drug product is approved in the country of origin, the Subject Expert Committee (SEC), functional under the Central Drugs...
Fixed Dose Combination of Metformin-Voglibose Now CDSCO Approved Susmita Roy13 Sept 2025 6:20 PM ISTNew Delhi: The Central Drugs Standard Control Organisation (CDSCO) has clarified that the fixed-dose combination (FDC) of Voglibose 0.2 mg and...
Insufficient Efficacy, Safety Data: CDSCO Panel Rejects Zydus' Phase III CT Waiver Request for Voclosporin Susmita Roy13 Sept 2025 6:13 PM ISTNew Delhi: Citing lack of sufficient efficacy and safety data to prove that the dose requirement in the Indian population is adequate, the Subject...
Braille Labels, QR Code Voice Assistance on Drugs? CDSCO Seeks Stakeholder Comments Susmita Roy11 Sept 2025 2:55 PM ISTNew Delhi: The Central Drugs Standard Control Organisation (CDSCO) has invited public comments on a proposal to make medicines more accessible to...
AstraZeneca Gets SEC Approval to Conduct Phase IV Trial of Hyperkalemia Drug Sodium Zirconium Cyclosilicate Susmita Roy11 Sept 2025 1:58 PM ISTNew Delhi: The Subject Expert Committee (SEC) functioning under the Central Drug Standard Control Organisation (CDSCO), has granted approval to the...
CDSCO Panel Flags Inadequate Data, Withholds Pilot Study Nod for BPH Pulse Field Ablation Device Parthika Patel11 Sept 2025 1:51 PM ISTNew Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO), has withheld permission for a proposed...
CDSCO Criminal Prosecution Against IndiaMART Put on Hold by Delhi HC Till Sept 17 Susmita Roy10 Sept 2025 9:51 PM ISTNew Delhi: The Delhi High Court has directed the Central Drugs Standard Control Organisation (CDSCO) not to enforce its order initiating criminal...
Novo Nordisk Gets CDSCO Panel Nod for Rybelsus Label Update, Aligned with EMA Parthika Patel10 Sept 2025 9:36 PM ISTNew Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) has recommended approval of an updated...
CDSCO Eases Rules for Biopharma Research, Will Accept Lab Biosafety Committee Approvals Susmita Roy10 Sept 2025 8:31 PM ISTNew Delhi: With the aim of streamlining the regulatory process for biopharmaceutical manufacturers engaged in vaccine, recombinant DNA, and other...
Sun Pharma Fails to Secure CDSCO Nod for BE, Phase III Waiver on Sitagliptin, Glimepiride, Metformin FDC Susmita Roy7 Sept 2025 3:30 PM ISTNew Delhi: Citing the absence of supporting data for the proposed strength of the fixed-dose combination (FDC) of Sitagliptin phosphate monohydrate,...
Drug Safety Alert: IPC Flags Adverse Reactions linked to Tranexamic acid and Metoclopramide Susmita Roy7 Sept 2025 1:30 PM ISTNew Delhi: The Indian Pharmacopoeia Commission (IPC), in its latest drug safety alert for August, has reported safety signals indicating that the...
