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Regulatory Affairs

  • Biotech & Pharma Business,Clinical & Regulatory,Drug Discovery & Development,Therapeutic Areas

    Incannex links PSX-001 psilocybin programme to White House push on psychedelic mental health treatments

    Incannex Healthcare has said its PSX-001 oral synthetic psilocybin programme [...]

    May 14, 2026
  • Biotech & Pharma Business,Clinical & Regulatory,Digital & Data,Drug Discovery & Development

    Veristat acquires Certara regulatory and medical writing business

    Veristat has agreed to acquire Certara’s regulatory and medical writing [...]

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

    NICE expands Lokelma access for hyperkalaemia after draft recommendation

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

    May 5, 2026
  • Advanced Therapies,Clinical & Regulatory,Drug Discovery & Development,Pharmaceuticals and therapeutics,Therapeutic Areas

    BridgeBio submits FDA NDA for BBP-418 in limb-girdle muscular dystrophy type 2I/R9

    BridgeBio Pharma has submitted a New Drug Application (NDA) to [...]

    May 5, 2026
  • Clinical & Regulatory,Medical devices,Therapeutic Areas

    Medtronic expands Medicare access and FDA cleared options for MiniMed 780G diabetes system in the US

    Medtronic has announced a series of US regulatory and reimbursement [...]

    May 5, 2026
  • Biotech & Pharma Business,Clinical & Regulatory,Drug Discovery & Development,Manufacturing & Supply Chain

    Spore.Bio appoints Michael Miller as VP of scientific and regulatory affairs

    Spore.Bio has appointed Michael Miller as vp of scientific and [...]

    May 5, 2026
  • Advanced Therapies,Clinical & Regulatory,Opinion & Events,Pharmaceuticals and therapeutics,Therapeutic Areas

    Saphnelo self-administration Phase 3 trial meets primary endpoint in systemic lupus erythematosus

    AstraZeneca has reported positive interim results from the Phase 3 [...]

    May 5, 2026
  • Clinical & Regulatory,Medical devices,Opinion & Events,Pharmaceuticals and therapeutics

    Amber Implants secures FDA clearance for VCFix spinal system

    Amber Implants has received FDA 510(k) clearance for its VCFix [...]

    May 5, 2026
  • Clinical & Regulatory,Drug Discovery & Development,Manufacturing & Supply Chain,Opinion & Events

    Axplora expands Vizag API capacity and confirms FDA inspection success at Indian sites

    Axplora has announced a €6.5 million investment at its Vizag [...]

    May 5, 2026
  • Clinical & Regulatory,Digital & Data,Drug Discovery & Development

    Yseop on FDA’s AI push: Why structured, explainable content is the future of regulatory submissions

    As the FDA accelerates its use of generative AI in [...]

    May 5, 2026
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