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Results For "authorization"

350 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 receives first approval for Lynkuet in UK as treatment for vasomotor symptoms associated with menopause
Drug Approval | July 11, 2025

Bayer receives first approval for Lynkuet in UK as treatment for vasomotor symptoms associated with menopause

The UK authorization is based on positive results from the Phase III OASIS-1, -2, and -3 trials


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


Zydus Lifesciences to acquire 85.6 % stake in Amplitude Surgical
News | April 26, 2025

Zydus Lifesciences to acquire 85.6 % stake in Amplitude Surgical

The closing of the Block Acquisition is now expected to be completed by Q3 2025


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


Sanofi & Regeneron’s Dupixent receives Japanese marketing approval to treat patients with COPD
News | March 29, 2025

Sanofi & Regeneron’s Dupixent receives Japanese marketing approval to treat patients with COPD

Dupixent (dupilumab) approved as the first-ever biologic medicine in Japan for patients with Chronic Obstructive Pulmonary Disease (COPD)


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