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FDA

  • 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
  • Advanced Therapies,Clinical & Regulatory,Drug Discovery & Development,Pharmaceuticals and therapeutics,Therapeutic Areas

    FDA backs registration pathway for Obsidian’s melanoma TIL therapy

    Obsidian Therapeutics has enrolled the first patient in the registration-enabling [...]

    August 5, 2026
  • Biotech & Pharma Business,Clinical & Regulatory,Pharmaceuticals and therapeutics

    FDA approves Meitheal’s rapid-acting insulin biosimilar Garzulys

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

    July 31, 2026
  • Biotech & Pharma Business,Digital & Data,Drug Delivery & Formulation,Pharmaceuticals and therapeutics

    PolyPid’s D-PLEX100 receives FDA Priority Review for surgical site infection prevention

    PolyPid’s D-PLEX100 has been granted FDA Priority Review following acceptance [...]

    July 29, 2026
  • Clinical & Regulatory,Drug Discovery & Development,Pharmaceuticals and therapeutics,Research & Development

    HAYA Therapeutics wins FDA Fast Track designation for HTX-001 in heart disease

    HAYA Therapeutics has received FDA Fast Track designation for HTX-001, [...]

    July 29, 2026
  • Clinical & Regulatory,Drug Delivery & Formulation,Pharmaceuticals and therapeutics,Research & Development

    FDA allows Medicus Pharma to start SkinJect study in patients with Gorlin Syndrome

    Medicus Pharma has received FDA clearance to begin a Phase [...]

    July 28, 2026
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