Latest Fda Approval News

Dimerix Limited reported a 22% reduction in its FY2025 loss to $13.25 million, driven by strong licensing revenues and advancing its pivotal Phase 3 clinical trial for DMX-200. The company secured new global partnerships valued at up to AU$1.4 billion, bolstering its cash reserves and commercial prospects.

Telix Pharmaceuticals has received a Complete Response Letter from the FDA for its TLX250-CDx diagnostic agent, citing manufacturing concerns. The company plans immediate remediation and maintains its 2025 revenue guidance.

Imagion Biosystems reported a $1.66 million loss for the half-year ending June 2025 while progressing its MagSense® HER2 Imaging Agent towards a Phase 2 FDA trial and securing $3.5 million in new funding.

Mesoblast Limited is set to release its full-year financial results and operational highlights for 2025, spotlighting its FDA-approved cell therapy and expanding global partnerships.

Optiscan Imaging Limited has launched a $17.75 million fully underwritten entitlement offer to fund clinical trials, regulatory approvals, and product development. Peters Investments underwrites the offer, potentially increasing its stake to nearly 39%.

Optiscan Imaging Ltd has launched a fully underwritten $17.75 million entitlement offer to fund clinical trials and regulatory clearances for its medical devices, marking a pivotal step in its transition to a commercial medical device manufacturer.

Compumedics has reported record-breaking sales orders and revenues for FY25, driven by strong US market growth and SaaS adoption, setting the stage for an ambitious FY26 expansion.

Cleo Diagnostics reported a $4 million loss for FY2025 while making significant strides toward FDA approval of its novel ovarian cancer blood test. The company is progressing clinical trials and scaling manufacturing in preparation for market entry.

Holista Colltech has inked a binding supply and development agreement with US-based Regenerex Pharma to exclusively supply proprietary ovine collagen for advanced wound care products, targeting the lucrative US market initially with plans for global expansion.

Imricor Medical Systems reports significant regulatory approvals and clinical trial progress, positioning itself as a disruptive force in the growing electrophysiology market. With a strengthened commercial pipeline and solid cash reserves, the company is poised for a pivotal growth phase.

Imricor Medical Systems reported a sharp 52% revenue decline and a 92% increase in net loss for H1 2025, offset by a $42.8 million equity raise boosting liquidity. The company is investing heavily in European sales and clinical trials while pursuing FDA approval.

PolyNovo Limited reported a robust 28.9% increase in group sales to A$118.6 million for FY25, alongside a 151% surge in net profit after tax to A$13.2 million, driven by strong U.S. growth and key regulatory approvals.