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  • CDSCO (Central Drugs...

CDSCO (Central Drugs Standard Control Organisation) News - Page 23

Novartis concludes acquisition of Tourmaline Bio

CDSCO Panel Asks Novartis to Submit Revised Protocol, Dose Changes for Ianalumab Phase III Trial

Dr. Divya Colin1 Jun 2025 4:00 PM IST
New Delhi: Reviewing the Phase III clinical of the Ianalumab (VAY736) presented by Novartis, the Subject Expert Committee (SEC) functional under the...
Cipla, Hetero win bid to supply widely prescribed diabetes drug in China

Don't throw in the bin, please flush it! CDSCO dictum for these 17 medicines

Farhat Nasim31 May 2025 6:21 PM IST
New Delhi: In a move to streamline the disposal of expired or unused medicines, the Central Drugs Standard Control Organisation (CDSCO) has issued a...
AstraZeneca-Amgen Tezspire gets USFDA nod for chronic rhinosinusitis with nasal polyps

Justify Sample Size Hike in FDC Trial of Zibotentan-Dapagliflozin, CDSCO Panel Tells AstraZeneca

Dr. Divya Colin31 May 2025 6:04 PM IST
New Delhi: Reviewing the amendment protocol of the AstraZeneca's fixed dose combination (FDC) Zibotentan plus Dapagliflozin, the Subject Expert...
Bayer Lynkuet approved in EU for hot flashes

Bayer Gets CDSCO Panel Nod To Conduct Phase 3 Trial for Finerenone

Dr. Divya Colin31 May 2025 5:56 PM IST
New Delhi: Bayer Pharmaceutical has received approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control...
Dr. Reddy

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 IST
New Delhi: In response to the proposal presented by the Dr Reddy's Laboratories, the Subject Expert Committee (SEC) functional under the Central Drug...
Sanofi India appoints Haresh Vala as Company Secretary, Compliance Officer

CDSCO Panel Clears Sanofi's Updated Myozyme Insert, Seeks Revision on Administration Guidance

Dr. Divya Colin30 May 2025 7:15 PM IST
New 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

CDSCO Committee Recommends SpinoS to Conduct BE Study with Vitamin D Screening Conditions

Dr. Divya Colin30 May 2025 1:00 PM IST
New Delhi: The SpinoS Lifescience And Research has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard...
Health Ministry Revises BA/BE Study Rules: Minimum Sample Size Set at 18

Only Licensed Importers Can Overprint Labels Under Rule 104A, Clarifies CDSCO

Dr. Divya Colin29 May 2025 8:05 PM IST
New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has clarified that overprinting or stickering of drug products under the Drugs...
Ipca Pharma incorporates new wholly owned arm in Federal Republic of Germany

Expert Panel Tells IPCA to Revise Hydroxychloroquine Phase III Trial for Diabetes

Dr. Divya Colin28 May 2025 11:35 PM IST
New 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

CDSCO Panel Accepts BE Report, Tells Intas Pharma to Conduct Phase III Trial for Semaglutide

Dr. Divya Colin28 May 2025 3:00 PM IST
New Delhi: In response to a proposal submitted by Intas Pharmaceuticals, the Subject Expert Committee (SEC) under the Central Drugs Standard Control...
Centre Lists 34 Antimicrobials, Antivirals for Proposed Ban in Animals Under Drugs Act

Centre Lists 34 Antimicrobials, Antivirals for Proposed Ban in Animals Under Drugs Act

Farhat Nasim27 May 2025 7:39 PM IST
New Delhi: The Central Government has issued a draft notification proposing the prohibition of import, manufacture, sale, and distribution of a total...
Abbott Told to Provide Prescribing Details, Supporting Data for Triamcinolone Hexacetonide Pre-Filled Syringe

CDSCO Panel Clears Abbott's Phase IV Trial for Empagliflozin + Metformin FDC, Seeks More Sites

Dr. Divya Colin26 May 2025 8:00 PM IST
New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has granted approval to Abbott Healthcare...
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Editorial

Effect of Micronized Purified Flavonoid Fraction (MPFF) in Indian patients with Grade I-II Hemorrhoids: the IMPACT HD Study

Effect of Micronized Purified Flavonoid Fraction (MPFF) in Indian patients with Grade I-II...

Gliclazide - Revisiting a Preferred Sulphonylurea in 2025 - Dr Silima Tarenia and Dr Shehzad Ruman

Gliclazide - Revisiting a Preferred Sulphonylurea in 2025 - Dr Silima Tarenia and Dr Shehzad Ruman

Aspirin in Obese T2D with Atherogenic Dyslipidemia: Identifying the Ideal Candidates

Aspirin in Obese T2D with Atherogenic Dyslipidemia: Identifying the Ideal Candidates

Explainer video: Advise- Educating Patients about Addressing Glycemic and Weight Goals

Explainer video: Advise- Educating Patients about Addressing Glycemic and Weight Goals

Risk Beyond Control: Inherited and Causal CV Risk Factors and the Role of Aspirin

Risk Beyond Control: Inherited and Causal CV Risk Factors and the Role of Aspirin

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Daily Black Cumin Intake Enhances Blood Lipid Profiles, Lowers Obesity Risk: Study Shows

Daily Black Cumin Intake Enhances Blood Lipid Profiles, Lowers Obesity Risk: Study Shows

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Health Bulletin 20/November/2025

Health Bulletin 20/November/2025

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