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1622 News Found

Biocon Biologics receives MHRA UK approval for Vevzuo and Evfraxy, Denosumab Biosimilars
News | July 07, 2025

Biocon Biologics receives MHRA UK approval for Vevzuo and Evfraxy, Denosumab Biosimilars

Vevzuo is authorized for the prevention of skeletal related events in adults with advanced malignancies involving bone


argenx advances clinical development of agonist antibody for myasthenic syndromes
News | July 04, 2025

argenx advances clinical development of agonist antibody for myasthenic syndromes

ARGX-119 is the sixth molecule developed through our Immunology Innovation Program to show proof-of-concept


Asahi Kasei Pharma starts Phase III study of promising CIPN prevention therapy
News | July 03, 2025

Asahi Kasei Pharma starts Phase III study of promising CIPN prevention therapy

ART-123 is a recombinant human thrombomodulin approved in Japan in 2008


Indegene identified as leader in ISG's Provider Lens for life sciences digital services
News | July 01, 2025

Indegene identified as leader in ISG's Provider Lens for life sciences digital services

ISG acknowledged Indegene's strengths in implementing holistic creative workflows, interoperability via robust integration with tech ecosystems


European Commission approves Eylea 8 mg with extended 6-month treatment interval for nAMD and visual impairment due to DME
Drug Approval | June 28, 2025

European Commission approves Eylea 8 mg with extended 6-month treatment interval for nAMD and visual impairment due to DME

Eylea 8 mg is the first and only anti-vascular endothelial growth factor (VEGF) treatment in the EU with treatment intervals of up to 6 months for both patients with nAMD and DME


EMA starts review of sodium oxybate in alcohol dependence
Policy | June 28, 2025

EMA starts review of sodium oxybate in alcohol dependence

Review will evaluate effectiveness in treating alcohol withdrawal syndrome and supporting abstinence, as well as measures to mitigate risk of abuse


Biocon Biologics receives Health Canada approval for Yesafili
Drug Approval | June 27, 2025

Biocon Biologics receives Health Canada approval for Yesafili

The approval is based on a comprehensive package of analytical, nonclinical, and clinical data


Philogen withdraws marketing authorization application for Nidlegy in EU
News | June 26, 2025

Philogen withdraws marketing authorization application for Nidlegy in EU

The company's decision to withdraw the MAA was due to the timing of the availability of Chemistry Manufacturing and Controls


Datroway approved in the US for patients with previously treated advanced EGFR-mutated non-small cell lung cancer
News | June 24, 2025

Datroway approved in the US for patients with previously treated advanced EGFR-mutated non-small cell lung cancer

First and only TROP2-directed therapy approved in the US for the treatment of lung cancer


Merck announces Phase 3 hyperion study of Winrevair met primary endpoint in recently diagnosed adults with PAH
Diagnostic Center | June 24, 2025

Merck announces Phase 3 hyperion study of Winrevair met primary endpoint in recently diagnosed adults with PAH

WINREVAIR significantly reduced the risk of clinical worsening events in recently diagnosed PAH patients over 70 percent of whom were on double background therapy