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Results For "marketing-authorization"

183 News Found

Briefs: Emcure Pharmaceuticals and Gland Pharma
News | July 12, 2025

Briefs: Emcure Pharmaceuticals and Gland Pharma

Emcure Pharmaceuticals successfully completes USFDA PAI of Oncology facility


Bayer submits EU application for Gadoquatrane MRI contrast agent
News | July 11, 2025

Bayer submits EU application for Gadoquatrane MRI contrast agent

It is intended for contrast enhancement in MRI scans


Lupin and Sino Universal Pharmaceuticals sign license and supply agreement for tiotropium DPI in China
News | June 17, 2025

Lupin and Sino Universal Pharmaceuticals sign license and supply agreement for tiotropium DPI in China

SUP will obtain regulatory approvals for selling Tiotropium DPI in China


Briefs: Dr. Reddy's Laboratories, Relonchem,  Shilpa Pharma Lifesciences and Shanmuga Hospital
News | May 18, 2025

Briefs: Dr. Reddy's Laboratories, Relonchem, Shilpa Pharma Lifesciences and Shanmuga Hospital

Shilpa Pharma Lifesciences, Unit-1, received EIR from USFDA


CuraTeQ Biologics completes Phase 1 Pharmacokinetics study of biosimilar Denosumab
News | April 09, 2025

CuraTeQ Biologics completes Phase 1 Pharmacokinetics study of biosimilar Denosumab

This study enrolled a total of 204 healthy volunteers into three groups to compare BP16 with the reference products, Prolia, obtained from both the EU and US markets


Lilly launches Mounjaro in India for treatment of obesity and type 2 diabetes
News | March 24, 2025

Lilly launches Mounjaro in India for treatment of obesity and type 2 diabetes

Adults taking Mounjaro with diet and exercise in a controlled clinical trial lost on average 21.8 kg at the highest dose (15mg) and 15.4 kg at the lowest dose (5mg)


Briefs: Zydus, Alkem Laboratories, Alkem Medtech and Relonchem
Drug Approval | March 19, 2025

Briefs: Zydus, Alkem Laboratories, Alkem Medtech and Relonchem

Alkem Medtech to acquire 100% stake of Bombay Ortho


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


Briefs: Emcure and Relonchem
Drug Approval | February 27, 2025

Briefs: Emcure and Relonchem

USFDA inspection at Emcure Pharmaceuticals API facility


Bayer files for approval of finerenone in heart failure in Japan
News | February 15, 2025

Bayer files for approval of finerenone in heart failure in Japan

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