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FDA Approval

  • Clinical & Regulatory,Pharmaceuticals and therapeutics,Therapeutic Areas

    Grifols secures expanded FDA label for Thrombate to include pediatric hereditary antithrombin deficiency

    Grifols has received US FDA approval for an expanded indication [...]

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

    FDA approves Kura and Kyowa Kirin’s ziftomenib for relapsed or refractory AML

    The US Food and Drug Administration (FDA) has approved KOMZIFTI [...]

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

    GSK’s depemokimab backed by Phase 3 data ahead of FDA decision in asthma and sinusitis

    Phase 3 data for GSK’s depemokimab appear to support the [...]

    May 5, 2026
  • Advanced Therapies,Biotech & Pharma Business,Manufacturing & Supply Chain,Opinion & Events,Pharmaceuticals and therapeutics,Therapeutic Areas

    Er-Kim to commercialize Nulibry and Zokinvy across Central and Eastern Europe, Mediterranean and Eurasia

    Er-Kim has signed an agreement with Sentynl Therapeutics to distribute [...]

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

    J&J halts Imaavy rheumatoid arthritis trial after no added benefit

    Johnson & Johnson has dropped plans to develop its recently [...]

    May 5, 2026
  • Clinical & Regulatory,Therapeutic Areas

    FDA approves BRINSUPRI as first treatment for non-cystic fibrosis bronchiectasis

    Insmed Incorporated, a global biopharmaceutical company focused on serious diseases, [...]

    May 5, 2026
  • Biotech & Pharma Business,Clinical & Regulatory,Drug Discovery & Development,Medical devices

    TISSIUM secures FDA De Novo nod for sutureless nerve repair system

    TISSIUM has received De Novo authorization from the US Food [...]

    May 5, 2026
  • Biotech & Pharma Business,Clinical & Regulatory,Drug Discovery & Development,Opinion & Events

    Cybin teams up with Osmind to advance Phase 3 psychedelic therapy for depression

    As psychedelic-assisted therapies move closer to mainstream psychiatric care, Cybin, [...]

    May 5, 2026
  • Biotech & Pharma Business,Clinical & Regulatory

    Genetically engineered pig liver enters first-in-human trial for patients with no transplant option

    OrganOx and eGenesis launch human trial of a genetically modified [...]

    May 5, 2026
  • Opinion & Events

    Beyond the band-aid: Brixton Biosciences’ drug-free revolution in pain management

    In the midst of an opioid crisis and growing frustration [...]

    May 5, 2026
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