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Results For "marketing-authorization"

160 News Found

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


Wockhardt’s Zaynich achieves highest-ever efficacy meeting superiority in a global, pivotal, registration- enabling Phase III study
Diagnostic Center | February 03, 2025

Wockhardt’s Zaynich achieves highest-ever efficacy meeting superiority in a global, pivotal, registration- enabling Phase III study

Such combined efficacy (achieving clinical cure and microbiologic cure) of Zaynich is highest ever among all the FDA-approved novel antibiotics developed in the last more than 10 years


Bayer’s investigational MRI contrast agent gadoquatrane meets primary and main secondary endpoints in pivotal Phase III studies
Diagnostic Center | January 10, 2025

Bayer’s investigational MRI contrast agent gadoquatrane meets primary and main secondary endpoints in pivotal Phase III studies

QUANTI clinical development program evaluated the efficacy and safety of the investigational MRI contrast agent gadoquatrane for a broad range of potential indications and in pediatric and adult patients


Biocon Biologics embarks on a three-stage strategic journey
News | January 08, 2025

Biocon Biologics embarks on a three-stage strategic journey

Successfully transformed the organization from a two-country operation focused on development and manufacturing to a fully integrated company with a strong commercial engine bringing us closer to patients in over 120 countries