EU regulator recommends revoking approval for Novartis’ sickle cell disease drug
The EMA’s human medicines committee concluded that the benefits of Adakveo did not outweigh its risks
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Tag: European Medicines Agency
EMA accepts application for leukaemia drug from Otsuka and Astex
The marketing authorisation application is supported by results from a phase 3 trial for AML
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EMA accepts Mundipharma’s application for candidiasis drug rezafungin
Despite current treatments, the mortality rate for patients with invasive candidiasis remains high
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CHMP recommends Nucala for three new indications
Positive opinions recommend approval for mAb in three additional eosinophil-driven diseases
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EMA fast-tracks Marinus Pharma’s rare epilepsy treatment
Accelerated assessment granted for company’s lead product candidate ganaxolone
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EMA accepts BMS’ Opdivo application in oesophageal cancer
Phase III trial showed significant survival benefit over chemotherapy alone
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BioMarin resubmits haemophilia A gene therapy to the EMA
Company initially withdrew a marketing authorisation application for the gene therapy last year
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EMA PRIME status granted for Vertex, CRISPR Therapeutics’ gene therapy CTX001
CRISPR/Cas9 gene-edited therapy is being investigated in transfusion-dependent beta thalassemia
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Roche’s Enspryng leads latest CHMP recommendations
CHMP adopted positive opinions for eight new medicines in its April meeting
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Amylyx Pharma plans to file ALS therapy with the EMA this year
The previously-reported CENTAUR study of AMX0035 in 137 participants with ALS met its primary endpoint of slowing ALS progression
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Five new meds recommended in March CHMP decisions
The committee also recommended six extensions of current therapeutic indications
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EMA accepts Astellas/Seagen’s enfortumab vedotin for review
Marketing authorisation application is seeking approval for advanced urothelial cancer
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- US study reveals interferon combinations cause lupus symptoms and affect treatment
- NIHR and TJBCM announce new funding initiative for novel brain tumour research
- UKHSA and ICL confirm variant which plays key role in global surge of Strep A infections
- Study reveals heart failure device could monitor patients and prevent hospitalisation
- MIT’s new MRI brain light-detecting technique could support brain cell studies
