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EMA

  • Clinical Development,Drug approval,Genetic Diseases,Rare Diseases,Regulatory Affairs

    Pegunigalsidase alfa every four weeks dosing backed by CHMP for adult Fabry patients

    The European Medicines Agency’s Committee for Medicinal Product for Human [...]

    February 2, 2026
  • Orphan drugs,Rare Diseases,Regulatory Affairs

    EMA grants orphan drug designation to Kedrion treatment for congenital aceruloplasminemia

    Kedrion has received orphan drug designation from the European Medicines [...]

    November 27, 2025
  • Drug approval,Oncology,Pharmaceuticals and therapeutics

    Otsuka submits EMA application for Inaqovi and venetoclax combination to treat acute myeloid leukaemia

    Otsuka Pharmaceutical Europe has submitted a marketing authorisation application (MAA) [...]

    November 7, 2025
  • Chronic diseases,Clinical Trials,Pharmaceuticals and therapeutics,Regulatory Affairs

    Tezspire recommended for EU approval for chronic rhinosinusitis with nasal polyps

    AstraZeneca and Amgen’s Tezspire (tezepelumab) has received a positive opinion [...]

    September 23, 2025
  • Biotech,Global health,Pharmaceuticals and therapeutics,Research & Development

    MaaT Pharma reports strong Phase 3 results and EMA submission for Xervyteg

    MaaT Pharma (EURONEXT: MAAT), a clinical-stage biotech focused on microbiome-based [...]

    September 22, 2025
  • Drug Development,Neurosciences,Rare Diseases,Regulatory Affairs

    SOM Biotech secures EMA orphan designation opinion for Huntington’s drug SOM3355

    Barcelona-based biotech advances Huntington’s programme as EMA backs orphan designation, [...]

    September 15, 2025
  • Clinical Trials,Global health,Oncology,Precision medicine,Rare Diseases,Regulatory Affairs,Research & Development

    CHMP backs Gilead’s twice-yearly lenacapavir for HIV prevention under accelerated EMA review

    Gilead Sciences has received a positive opinion from the Committee [...]

    July 25, 2025
  • Biologics & Biosimilars,CDMOs & Manufacturing,Cell & Gene Therapy,Regulatory Affairs

    Is Europe rising? How global pharma uncertainty is fuelling a new era for European innovation

    As global pharma grapples with shifting regulations, rising geopolitical tensions, [...]

    June 8, 2025
  • Cell & Gene Therapy,Clinical Trials,Drug Development

    MaaT Pharma submits EMA application for Xervyteg in graft-versus-host disease

    MaaT Pharma has submitted a marketing authorisation application (MAA) to [...]

    June 2, 2025
  • Artificial Intelligence,Technology and platforms,Women in Pharma

    AI governance in pharmacovigilance: Marie Flanagan calls for safety-specific frameworks to safeguard patient risk

    The integration of artificial intelligence into pharmacovigilance is prompting a [...]

    June 2, 2025
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