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1089 News Found

USFDA grants Priority Review for new indication of finerenone for patients with common heart failure
Drug Approval | March 20, 2025

USFDA grants Priority Review for new indication of finerenone for patients with common heart failure

Finerenone is the first drug targeting the mineralocorticoid receptor (MR) pathway to demonstrate cardiovascular benefits in a Phase III study in patients with heart failure


ZIM Laboratories receives marketing authorization for Dimethyl Fumarate in Portugal
News | March 20, 2025

ZIM Laboratories receives marketing authorization for Dimethyl Fumarate in Portugal

Dimethyl Fumarate Modified Release Capsules are indicated for the treatment of relapsing forms of multiple sclerosis


RedHill Biopharma to submit FDA-approved Talicia for UK marketing authorisation
Drug Approval | March 19, 2025

RedHill Biopharma to submit FDA-approved Talicia for UK marketing authorisation

Talicia is also approved and launched in the UAE and additional countries may accept UK MHRA approvals as a reference for their own marketing approval processes


Shilpa Biologicals partners with mAbTree Biologics AG for a novel immunooncology asset
News | March 18, 2025

Shilpa Biologicals partners with mAbTree Biologics AG for a novel immunooncology asset

This program aims to develop a fully human monoclonal antibody against a novel immune checkpoint protein that enables T cell activation


Nectar Lifesciences receives 7 observations from EDQM for API facility
News | March 12, 2025

Nectar Lifesciences receives 7 observations from EDQM for API facility

The European regulator will conduct a re-inspection of the facility to verify the compliance


Zota Health Care launched B2C online portal ‘davaindia’
Healthcare | March 11, 2025

Zota Health Care launched B2C online portal ‘davaindia’

This e-commerce platform is launched as a hyperlocal model


Biocon Biologics announces positive results from Phase 3 study of Yesintek biosimilar to Ustekinumab for chronic plaque psoriasis
Diagnostic Center | March 08, 2025

Biocon Biologics announces positive results from Phase 3 study of Yesintek biosimilar to Ustekinumab for chronic plaque psoriasis

The study demonstrated equivalent efficacy, safety, immunogenicity, and pharmacokinetics between YESINTEK and the reference product Stelara


Biocon Biologics and Civica collaborate to expand Insulin Aspart access in US
News | March 07, 2025

Biocon Biologics and Civica collaborate to expand Insulin Aspart access in US

There are 38.4 million people with diabetes in the United States


Briefs: Alembic Pharma and IOL Chemicals and Pharmaceuticals
Drug Approval | March 07, 2025

Briefs: Alembic Pharma and IOL Chemicals and Pharmaceuticals

USFDA inspection at Alembic Pharma's Bioequivalence facility


Venus Remedies secures firstiInternational market authorization for Sugammadex from the Philippines
Drug Approval | March 04, 2025

Venus Remedies secures firstiInternational market authorization for Sugammadex from the Philippines

The approval marks Venus Remedies’ strategic entry into complex generics, expanding its injectable portfolio beyond traditional formulations