Latest Fda News

Algorae Pharmaceuticals has signed a binding term sheet with India’s Cadila Pharmaceuticals to introduce two generic medicines targeting cardiovascular and metabolic disorders in Australia and New Zealand.

Race Oncology showcased compelling preclinical data at ESMO 2025 revealing that their drug RC220, combined with doxorubicin, not only shields the heart from toxicity but also boosts anticancer effects, supporting ongoing clinical trials.

Orthocell has boosted its investment in Marine Biomedical to secure exclusive global distribution rights for PearlBone™, an innovative bone substitute nearing FDA approval, enhancing its regenerative medicine portfolio.

Immutep’s novel immunotherapy combination with KEYTRUDA and chemotherapy shows promising response rates in first line non-small cell lung cancer, especially in patients with low or no PD-L1 expression.

Orthocell has raised $30 million through an institutional placement to accelerate the US commercialisation of its flagship nerve repair product Remplir and expand its regenerative medicine portfolio.

PainChek Limited has confirmed FDA De Novo classification for its PainChek Adult App, promptly disclosing the material regulatory milestone to the ASX and signalling a significant step towards US market entry.

Anteris Technologies has secured its first European regulatory clearance to commence the global PARADIGM Trial for its DurAVR Transcatheter Heart Valve, marking a significant step toward worldwide commercialization.

Biotron Limited is set to acquire Sedarex Limited, gaining global patents for SedRx, a next-generation general anaesthetic, supported by a $2.5 million capital raising to fund regulatory and development milestones.

Compumedics has secured a $2.15 million placement to fast-track commercialisation of its Somfit D device following early FDA approval, positioning the company for significant growth in the US home sleep testing market.

Argenica Therapeutics reports encouraging functional improvements in stroke patients treated with ARG-007, setting the stage for a targeted Phase 2b trial focused on patient-centered outcomes.

Telix Pharmaceuticals reports a robust 53% revenue jump in Q3 2025 and raises its full-year guidance, underpinned by key reimbursement wins and expanding clinical programs.

Clarity Pharmaceuticals’ Co-PSMA Phase II trial shows its Cu-SAR-bisPSMA diagnostic agent detects more prostate cancer lesions than current standard imaging, promising earlier and more accurate recurrence detection.