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Results For "authorization"

302 News Found

Bayer’s Nubeqa receives EU approval for patients with advanced prostate cancer
Drug Approval | July 21, 2025

Bayer’s Nubeqa receives EU approval for patients with advanced prostate cancer

European Commission granted approval of darolutamide in combination with androgen deprivation therapy (ADT) for patients with metastatic hormone-sensitive prostate cancer (mHSPC)


Moderna receives USFDA approval for Covid-19 vaccine ‘Spikevax’
Drug Approval | July 13, 2025

Moderna receives USFDA approval for Covid-19 vaccine ‘Spikevax’

Spikevax is now approved for all individuals aged 6 months through 64 years at increased risk for COVID-19 disease


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)