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3985 News Found

Ascendis Pharma’s FDA review of Achondroplasia drug gets 3-month delay
Drug Approval | November 30, 2025

Ascendis Pharma’s FDA review of Achondroplasia drug gets 3-month delay

The FDA has classified recent submissions as a major amendment pushing the approval to its NDA for TransCon CNP back three months to February 28, 2026


Biocon Biologics' Drug Substance Facility in Bengaluru cassified as VAI
Drug Approval | November 29, 2025

Biocon Biologics' Drug Substance Facility in Bengaluru cassified as VAI

This relates to the manufacture and supply of Human Recombinant Insulin (rh- Insulin) and Biosimilar Pegfilgrastim Drug Substance to the United States


Mangalam Drugs receives Rs. 15 crore repeat export order
News | November 29, 2025

Mangalam Drugs receives Rs. 15 crore repeat export order

The receipt of this order further strengthens the company's position in the global pharmaceutical market


Ovation.io and PrecisionLife team to develop drug-response biomarkers for GLP-1 therapies
R&D | November 28, 2025

Ovation.io and PrecisionLife team to develop drug-response biomarkers for GLP-1 therapies

GLP-1 therapies are among the fastest-growing drug classes worldwide, projected to drive a $95 billion obesity market by 2030


Akums Drugs appoints Yuvraj Datta as President – Operational Strategy & Excellence
People | November 28, 2025

Akums Drugs appoints Yuvraj Datta as President – Operational Strategy & Excellence

Most recently, Yuvraj was the Director of Operations, Business Development & Process Excellence at Zeon Lifesciences Ltd


Novo Nordisk fast-tracks higher-dose obesity drug to FDA
Clinical Trials | November 27, 2025

Novo Nordisk fast-tracks higher-dose obesity drug to FDA

The drug, intended for chronic weight management alongside diet and exercise, is now under the FDA’s new CNPV expedited review pathway


Otsuka files FDA application for first-in-class ADHD drug
Clinical Trials | November 27, 2025

Otsuka files FDA application for first-in-class ADHD drug

Centanafadine is a first-in-class norepinephrine, dopamine, and serotonin reuptake inhibitor


Novo Nordisk’s new diabetes combo drug delivers big wins in mid-stage trial
Clinical Trials | November 26, 2025

Novo Nordisk’s new diabetes combo drug delivers big wins in mid-stage trial

The trial tested six injectable doses and three oral doses over as long as 36 weeks


Gilead delivers groundbreaking HIV prevention drug to Eswatini & Zambia
Biopharma | November 25, 2025

Gilead delivers groundbreaking HIV prevention drug to Eswatini & Zambia

The deliveries bring the innovative medicine to communities heavily impacted by HIV just five months after U.S. FDA approval