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EMA

  • Advanced Therapies,Clinical & Regulatory,Therapeutic Areas

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

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

    May 5, 2026
  • Advanced Therapies,Clinical & Regulatory,Therapeutic Areas

    EMA grants orphan drug designation to Kedrion treatment for congenital aceruloplasminemia

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

    May 5, 2026
  • Clinical & Regulatory,Pharmaceuticals and therapeutics,Therapeutic Areas

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

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

    May 5, 2026
  • Clinical & Regulatory,Pharmaceuticals and therapeutics,Therapeutic Areas

    Tezspire recommended for EU approval for chronic rhinosinusitis with nasal polyps

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

    May 5, 2026
  • Biotech & Pharma Business,Drug Discovery & Development,Opinion & Events,Pharmaceuticals and therapeutics

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

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

    May 5, 2026
  • Clinical & Regulatory,Drug Discovery & Development,Therapeutic Areas

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

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

    May 5, 2026
  • Clinical & Regulatory,Drug Discovery & Development,Opinion & Events,Therapeutic Areas

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

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

    May 5, 2026
  • Advanced Therapies,Clinical & Regulatory,Manufacturing & Supply Chain

    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, [...]

    May 5, 2026
  • Advanced Therapies,Clinical & Regulatory,Drug Discovery & Development

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

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

    May 5, 2026
  • Digital & Data,Drug Discovery & Development,Opinion & Events

    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 [...]

    May 5, 2026
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