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BioWorld - Wednesday, June 3, 2026

TGA

Home » Topics » Regulatory » TGA
  • Ausbiotech tracy duffy 5 21
    May 26, 2026
    By Tamra Sami

    AI, remote care drive new models for Australian medtech

    Artificial intelligence, remote monitoring and need-based innovation are beginning to reshape Australia’s medtech sector’s devices, as well as the way health care itself is delivered, according to speakers at the 2026 Ausmedtech conference in Perth May 19-20.
  • Cancer prostate illustration
    May 22, 2026

    Henlius gains Australian trial clearance for HLX-3902

    Shanghai Henlius Biotech Inc.’s HLX-3902, a trispecific antibody targeting STEAP1xCD3xCD28, has received approval from the Human Research Ethics Committee (HREC) in Australia and has been filed with the Therapeutic Goods Administration (TGA). The T-cell engager is intended for the treatment of metastatic castration-resistant prostate cancer and other advanced solid tumors.
  • May 22, 2026

    Scribe’s STX-1150 for hypercholesterolemia cleared for clinic

    Scribe Therapeutics Inc. has obtained clearance from Australia’s Therapeutic Goods Administration (TGA) to initiate a first-in-human study of STX-1150 for the treatment of hypercholesterolemia, a major driver of atherosclerotic cardiovascular disease (ASCVD). The phase I study will enroll adults with elevated LDL-C at increased cardiovascular risk at sites in Australia and New Zealand.
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Authors

  • Tamra Sami
  • Mark McCarty
  • Mari Serebrov
  • Holland Johnson
  • David Ho
  • Marian (YoonJee) Chu
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