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Results For "European-Medicines-Agency"

222 News Found

EMA recommends authorization of Teizeild to delay Type 1 diabetes onset
Drug Approval | November 17, 2025

EMA recommends authorization of Teizeild to delay Type 1 diabetes onset

This is the first drug to receive a recommendation for this preventative indication in the European Union


Roche’s Gazyva shows breakthrough efficacy in phase III lupus study
Clinical Trials | November 04, 2025

Roche’s Gazyva shows breakthrough efficacy in phase III lupus study

The ALLEGORY study demonstrated statistically significant improvements in key measures, including British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response


Roche’s Gazyva shows strong phase III results for treatment of idiopathic nephrotic syndrome
Clinical Trials | October 30, 2025

Roche’s Gazyva shows strong phase III results for treatment of idiopathic nephrotic syndrome

Key secondary endpoints also demonstrated statistically significant and clinically meaningful benefits with Gazyva


Lilly buys Adverum for its phase 3-stage eye disease gene therapy
Biotech | October 27, 2025

Lilly buys Adverum for its phase 3-stage eye disease gene therapy

Adverum's lead program, Ixo-vec, is a Phase 3 gene therapy designed to treat vision loss associated with wet age-related macular degeneration with a single intravitreal dose


Ipsen to acquire ImCheck Therapeutics to strengthen oncology pipeline
News | October 23, 2025

Ipsen to acquire ImCheck Therapeutics to strengthen oncology pipeline

The acquisition centers on ImCheck’s lead Phase I/II program, ICT01, a first-in-class monoclonal antibody targeting BTN3A


FDA approves Roche’s kidney inflammation drug
Drug Approval | October 22, 2025

FDA approves Roche’s kidney inflammation drug

Gazyva/Gazyvaro is the only anti-CD20 monoclonal antibody to demonstrate a complete renal response benefit in lupus nephritis in a randomised phase III study


Dr. Reddy's receives positive CHMP opinion from EMA for denosumab 'AVT03'
News | September 24, 2025

Dr. Reddy's receives positive CHMP opinion from EMA for denosumab 'AVT03'

Prolia is a prescription medicine used to treat osteoporosis in women


AstraZeneca’s Koselugo recommended for approval in the EU for Neurofibromatosis type 1
Drug Approval | September 24, 2025

AstraZeneca’s Koselugo recommended for approval in the EU for Neurofibromatosis type 1

The positive opinion is based on results from KOMET, the largest and only placebo-controlled, double-blind global Phase III trial in this patient population


AstraZeneca’s Tezspire recommended for approval in the EU for chronic Rhinosinusitis with nasal polyps
News | September 23, 2025

AstraZeneca’s Tezspire recommended for approval in the EU for chronic Rhinosinusitis with nasal polyps

Tezspire nearly eliminated the need for surgery, reducing surgical intervention by 98 per cent