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Drug approval

  • Drug approval,Drug Development,Immunology

    Saphnelo self-administration recommended for EU approval for systemic lupus

    AstraZeneca has received a positive recommendation from the Committee for [...]

    December 4, 2025
  • Clinical Development,Clinical Trials,Drug approval,Hematology,Oncology,Pharmaceuticals and therapeutics

    Talquetamab recommended by NICE for relapsed and refractory multiple myeloma

    The National Institute for Health and Care Excellence (NICE) has [...]

    November 17, 2025
  • Biologics & Biosimilars,Drug approval,European biotech,Hematology,Rare Diseases

    Grifols’ Biotest secures first approval for fibrinogen concentrate in Germany

    Grifols’ Biotest has received its first regulatory approval for a [...]

    November 14, 2025
  • Drug approval,Oncology,Pharmaceuticals and therapeutics

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

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

    November 13, 2025
  • Drug approval,Gastroenterology,Pharmaceuticals and therapeutics,Regulatory Affairs

    SMC accepts guselkumab for Crohn’s disease and ulcerative colitis in NHS Scotland

    The Scottish Medicines Consortium (SMC) has accepted guselkumab for the [...]

    November 12, 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
  • Biologics & Biosimilars,Clinical Development,Clinical Trials,Drug approval,Infectious Diseases,Pharmaceuticals and therapeutics,Regulatory Affairs,RNA Therapeutics

    Cidara Therapeutics receives FDA Breakthrough Therapy designation for CD388 in seasonal influenza prevention

    Cidara Therapeutics has received Breakthrough Therapy designation from the US [...]

    October 10, 2025
  • Clinical Trials,Drug approval,Pharmaceuticals and therapeutics,Respiratory

    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 [...]

    October 8, 2025
  • Cell & Gene Therapy,Clinical Trials,Drug approval,Rare Diseases,Research & Development

    AAVantgarde secures FDA orphan drug designation and UK trial approval for Stargardt gene therapy

    AAVantgarde Bio has received two regulatory milestones for its investigational [...]

    October 2, 2025
  • Biologics & Biosimilars,Drug approval,Drug Development,Market Access & Commercialization,Pharmaceuticals and therapeutics,Regulatory Affairs

    Biosimilars Forum highlights $181 billion in potential savings as lawmakers push for lower-cost medicines

    Proposed legislation aims to streamline biosimilar development and expand patient [...]

    September 30, 2025
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