Latest Regulatory Approval News

EMVision Medical Devices is set to activate its sixth and final pivotal trial site at UCLA Health, advancing its emu™ brain scanner towards FDA submission. Meanwhile, the Continuous Innovation Study grows with the addition of Box Hill Hospital.

Tyro Payments Limited reported FY25 results with strong top-line growth and margin expansion, setting a confident outlook for FY26 backed by AI-driven efficiency and an expanded market.

Scentre Group has announced its actual ordinary dividend for the six months ended June 2025, alongside detailed currency options and dividend reinvestment plan pricing.

Bio-Gene Technology Limited reported a net loss of AUD 2.58 million for FY2025 while making significant strides in developing its bio-insecticides Flavocide and Qcide, securing US Department of Defense grants and expanding global partnerships.

Zenith Minerals has secured final regulatory approval to commence Phase 2 of its RC drilling program at the Consolidated Dulcie Gold Project, aiming to convert a significant Exploration Target into a JORC-compliant resource.

Sparc Technologies reveals up to 60% corrosion reduction in graphene-enhanced water-based epoxy coatings, reinforcing its leadership in sustainable protective coatings innovation.

29Metals Limited has reversed a significant loss to report a $35.3 million net profit for the first half of 2025, driven by stronger production at Golden Grove and improved metal prices, while Capricorn Copper remains suspended amid ongoing water and regulatory challenges.

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.

Firebrick Pharma has secured an exclusive licensing agreement with Innorini Pte Ltd to distribute Nasodine products across Singapore, Malaysia, Brunei, and Mauritius, aiming to reduce marketing expenses and broaden market access.

Vulcan Steel Limited reported a 10.9% revenue decline in FY25 alongside a 24.1% drop in adjusted EBITDA, while announcing a fully underwritten NZ$96 million equity raise to fund the acquisition of Roofing Industries Limited. The deal marks Vulcan’s strategic entry into the New Zealand steel roofing and cladding market with expected earnings accretion and no change to its dividend policy.

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.