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FDA

  • Clinical & Regulatory,Pharmaceuticals and therapeutics,Therapeutic Areas

    Karyopharm seeks FDA accelerated approval for selinexor in myelofibrosis

    Karyopharm Therapeutics has submitted an application to the FDA seeking [...]

    September 14, 2026
  • Clinical & Regulatory,Pharmaceuticals and therapeutics

    FDA approves daraxonrasib for second-line pancreatic cancer

    The US FDA has approved Revolution Medicines’ daraxonrasib for adults [...]

    August 28, 2026
  • Clinical & Regulatory,Pharmaceuticals and therapeutics,Research & Development

    Sagimet prepares Phase 3 acne trial for first US patients

    Sagimet Biosciences is preparing to begin screening patients for its [...]

    August 27, 2026
  • Clinical & Regulatory,Drug Discovery & Development,Pharmaceuticals and therapeutics,Research & Development,Therapeutic Areas

    Polaryx advances Phase 2 trial of PLX-200 in four rare diseases

    Polaryx Therapeutics is preparing to start its Phase 2 SOTERIA [...]

    August 26, 2026
  • Clinical & Regulatory,Medical devices,Pharmaceuticals and therapeutics,Therapeutic Areas

    FDA grants De Novo authorisation to Avulux migraine light-sensitivity lens

    The FDA has granted De Novo marketing authorisation to Avulux, [...]

    August 24, 2026
  • Central Nervous System,Clinical & Regulatory,Digital & Data,Pharmaceuticals and therapeutics,Therapeutic Areas

    Limbic selected for FDA pilot to test AI-led mental healthcare

    Limbic has been selected for the US Food and Drug [...]

    August 19, 2026
  • Central Nervous System,Clinical & Regulatory,Drug Discovery & Development,Pharmaceuticals and therapeutics,Research & Development,Therapeutic Areas

    AC Immune gets FDA Fast Track for Parkinson’s immunotherapy ACI-7104

    AC Immune has received FDA Fast Track designation and IND [...]

    August 12, 2026
  • Clinical & Regulatory,Drug Discovery & Development,Pharmaceuticals and therapeutics

    FDA issues Complete Response Letter for ITM-11 over manufacturing issues

    The FDA has issued a Complete Response Letter for ITM-11, [...]

    August 11, 2026
  • Clinical & Regulatory,Drug Discovery & Development,Pharmaceuticals and therapeutics

    Adneuris licenses cebranopadol to Maruishi in $35M Japan and South Korea deal

    Adneuris Therapeutics has granted Maruishi Pharmaceutical exclusive rights to develop [...]

    August 7, 2026
  • Clinical & Regulatory,Medical devices,Therapeutic Areas

    BlueWind wins FDA clearance for longer-lasting Revi implant for urinary incontinence

    BlueWind Medical has received FDA 510(k) clearance for Revi Extend, [...]

    August 6, 2026
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