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  • CDSCO (Central Drugs...

CDSCO (Central Drugs Standard Control Organisation) News - Page 8

CDSCO Panel Approves Emcures Phase III Clinical Trial of Semaglutide, Mandates Govt Trial Sites

CDSCO Panel Approves Emcure's Phase III Clinical Trial of Semaglutide, Mandates Govt Trial Sites

Susmita Roy21 Aug 2025 6:53 PM IST
New Delhi: Accepting the bioequivalence (BE) study report, the Subject Expert Committee (SEC) functional under the Central Drugs Standard Control...
Revise Phase III Trial Protocol for Roflumilast Cream: CDSCO Panel Tells Sun Pharma

Revise Phase III Trial Protocol for Roflumilast Cream: CDSCO Panel Tells Sun Pharma

Susmita Roy20 Aug 2025 4:20 PM IST
New Delhi: Following a thorough discussion on the proposed Phase III clinical trial protocol for roflumilast cream, the Subject Expert Committee (SEC)...
Sun Pharma Halol facility gets OAI status from USFDA

Sun Pharma's Dapagliflozin, Glimepiride, Metformin FDC Fails to Secure CDSCO Panel Nod Over Safety, Utility Concerns

Susmita Roy19 Aug 2025 3:11 PM IST
New Delhi: Expressing doubts over the clinical utility of administering such a small dose of Glimepiride once daily, especially considering over the...
Submit BE Raw Data, Interaction Study on Dapagliflozin-Rosuvastatin FDC: Expert Panel Tells Pure and Cure

Submit BE Raw Data, Interaction Study on Dapagliflozin-Rosuvastatin FDC: Expert Panel Tells Pure and Cure

Susmita Roy19 Aug 2025 3:02 PM IST
New Delhi: In line with the proposal presented by Pure and Cure Healthcare for the Dapagliflozin plus Rosuvastatin film-coated tablet, the Subject...
Zydus Gets CDSCO Panel Nod to Market Sodium Chloride Nebuliser Solution

Regulatory Roadblock for Zydus: CDSCO Panel Halts MMRV Vaccine Trial, Seeks Adult Data

Dr. Divya Colin18 Aug 2025 4:15 PM IST
New Delhi: Zydus Lifesciences Limited's plan to conduct a Phase II/III clinical trial of its Measles, Mumps, Rubella and Varicella (MMRV) vaccine has...
Expert Panel Rejects Zuventus Trelagliptin PMS Plan, Seeks Higher Patient Enrolment

Expert Panel Rejects Zuventus' Trelagliptin PMS Plan, Seeks Higher Patient Enrolment

Parthika Patel18 Aug 2025 2:37 PM IST
New Delhi: Zuventus Healthcare Limited's proposal for the active post-marketing surveillance (PMS) study of Trelagliptin Tablets 25 mg, 50 mg and 100...
Bayer Gadoquatrane new drug application accepted for review by USFDA

Bayer Gets CDSCO Committee Nod to Manufacture, Market Darolutamide 300 mg for mHSPC, PMS Study Mandated

Susmita Roy18 Aug 2025 2:00 PM IST
New Delhi: Bayer Pharmaceuticals has got the go-ahead from the Subject Expert Committee (SEC) functioning under the Central Drugs Standard Control...
Dr Reddys Labs receives positive EMA Committee opinion for proposed biosimilar of Prolia, Xgeva

Dr Reddy's Secures CDSCO Panel Approval to Import, Market Olutasidenib for AML

Susmita Roy17 Aug 2025 4:00 PM IST
New Delhi: In a significant development, the pharmaceutical major, Dr. Reddy's Laboratories, has got the go-ahead from the Subject Expert Committee...
Sun Pharma exposed to some headline risk amid US tariff move, but with limited earnings impact

Sun Pharma Gets SEC Nod to Conduct Phase III Trial of Resmetirom Tablets

Dr. Divya Colin17 Aug 2025 3:00 PM IST
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has recommended allowing Sun...
Lupin Launches Strategic Partnership to Expand PrecisionSphere Long-Acting Injectable Platform

Lupin to Conduct BE Study for Synthetic Semaglutide Tablets in 3 Strengths

Parthika Patel15 Aug 2025 3:02 PM IST
New Delhi: Lupin Limited has received the green light from the Subject Expert Committee (SEC) under the Endocrinology & Metabolism division of the...
Sun Pharma Halol facility gets OAI status from USFDA

Sun Pharma Gets CDSCO Panel Nod for Active PMS of Fexuprazan Hydrochloride Tablets

Susmita Roy15 Aug 2025 2:31 PM IST
New Delhi: Sun Pharma Laboratories has got the go-ahead from the Subject Expert Committee (SEC) functioning under the Central Drugs Standard Control...
Setback to Torrent: CDSCO Panel Rejects Phase III Waiver Plea for Prucalopride Over Safety Data Gaps

Setback to Torrent: CDSCO Panel Rejects Phase III Waiver Plea for Prucalopride Over Safety Data Gaps

Susmita Roy14 Aug 2025 9:28 PM IST
New Delhi: Citing that Torrent Pharmaceuticals has not presented adequate safety data on the synergistic effect of added excipients (propylene glycol,...
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Editorial

Indias Unique CV Risk Profile: How to Decode the Role of Aspirin?

India's Unique CV Risk Profile: How to Decode the Role of Aspirin?

Vildagliptin-Dapagliflozin FDC Effective in High CV Risk Indian T2DM Patients: Findings from Latest DAa-ViNCI Study

Vildagliptin-Dapagliflozin FDC Effective in High CV Risk Indian T2DM Patients: Findings from Latest...

Tirzepatide proves to be more effective than semaglutide- Results of Surmount 5 Trial

Tirzepatide proves to be more effective than semaglutide- Results of Surmount 5 Trial

Pneumococcal Vaccination in Hematological Malignancies (HM)-Indian Hematology Expert Consensus 2025

Pneumococcal Vaccination in Hematological Malignancies (HM)-Indian Hematology Expert Consensus 2025

Negligence vs Misconduct: Where Do Medical Councils Draw the Line?

Negligence vs Misconduct: Where Do Medical Councils Draw the Line?

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Journal Club Today

Genome Sequencing in Newborns May Identify Life-Threatening Disorders Missed by Traditional Tests: Study Shows

Genome Sequencing in Newborns May Identify Life-Threatening Disorders Missed by Traditional Tests:...

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Health News Today

Health Bulletin 11/October/2025

Health Bulletin 11/October/2025

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