Browsing Tag
Therapeutic Goods Administration
7 posts
4DMedical wins Australian CT:VQ approval as ASX:4DX faces Medicare reimbursement test
4DMedical has gained regulatory access to its home market for CT:VQ, but the commercial value of Australia’s large CT scanner network will depend on hospital implementation, clinical confidence and Medicare reimbursement.
Avecho Biotechnology clears Phase III insomnia interim review as ASX:AVE surges 40%
Avecho Biotechnology’s CBD insomnia trial will continue with its original 519-patient design after an independent monitoring board found that predefined efficacy and safety requirements had been satisfied.
OncoSil Medical (OSL:ASX) has pancreatic cancer data momentum, but investors now need adoption proof
OSL has TRIPP-FFX data, TGA approval and FDA pathway momentum. The bigger test is whether OncoSil can turn evidence into adoption.
Archer Materials (AXE) advances Biochip to beta prototype as silicon-first strategy targets clinical validation
Archer Materials (ASX: AXE) advances its Biochip medical diagnostic to beta prototype, targeting clinical trials via silicon-first strategy and Stage 2 imec partnership. Read the full analysis.
Vaxxas’ TGA licence unlocks GMP production for HD-MAP vaccines: What this means for clinical trials and global delivery strategy
Vaxxas Pty Ltd wins TGA manufacturing licence for needle‑free HD‑MAP vaccines, enhancing clinical scale and delivery potential. Find out what this means next.
Avecho Biotechnology secures $19m+ deal with Sandoz for CBD insomnia treatment in Australia
Avecho Biotechnology Limited has entered an exclusive 10-year development and licensing agreement with Sandoz Group AG to commercialise…
Lincoln Pharma gets Australian TGA’s GMP clearance for Khatraj plant
India-based Lincoln Pharmaceuticals (Lincoln Pharma) has received approval from Australia’s medicines and medical devices regulator – Therapeutic Goods…