Latest Regulatory Approvals News

Opthea Limited has spotlighted Sozinibercept as a potential game-changer in wet age-related macular degeneration (AMD) therapy, presenting compelling clinical data and a clear path to U.S. market entry.

TrivarX has secured positive feedback from the FDA on its pivotal trial design for MEB-001, an AI-driven algorithm targeting major depressive episode screening via sleep study data. The company is advancing site collaborations to launch a large-scale US trial.

Mineral Commodities Ltd reports steady progress on its Munglinup graphite project and secures A$2.4 million in convertible loans, while navigating operational setbacks and a conditional sale of its Skaland asset.

Torque Metals Limited and Aston Minerals Limited have formalised a Scheme Implementation Agreement, setting the stage for Torque Metals to acquire Aston Minerals through a structured share and option scheme.

Torque Metals Limited and Aston Minerals Limited have formalised a Scheme Implementation Agreement, setting the stage for Torque Metals to acquire Aston Minerals through a structured share and option scheme.

Torque Metals and Aston Minerals have announced a merger to create a leading gold-focused explorer with combined resources of 1.75 million ounces, aiming to accelerate growth and exploration in premier gold regions of Australia and Canada.

Torque Metals and Aston Minerals have announced a merger of equals, combining their gold assets to create a diversified explorer with 1.75 million ounces of gold resources and enhanced growth potential.

APA Group has updated its dividend distribution announcement, adjusting for changes in the New Zealand dollar exchange rate and the Dividend Reinvestment Plan share price, with an estimated ordinary dividend of AUD 0.27 per security.

Po Valley Energy has secured crucial regional approval to launch a 3D seismic campaign over its Selva Malvezzi concession, paving the way for drilling four new wells.

OncoSil Medical has achieved a key regulatory milestone with MDR certification from BSI, removing post-market restrictions and streamlining its commercial operations across Europe. This approval also paves the way for renewed efforts to enter the Australian market.

Cosmos Exploration has secured an exclusive option to acquire EAU Lithium, partnering with Vulcan Energy to deploy cutting-edge Direct Lithium Extraction technology in Bolivia’s lithium-rich salars. This strategic move positions Cosmos at the forefront of sustainable lithium production in the world’s largest lithium resource base.

Dreadnought Resources has released a robust scoping study for its Star of Mangaroon gold project, targeting initial production of around 20,000 ounces at a high grade of 10 g/t. The study outlines strong financial metrics and sets the stage for potential production in 2025, backed by a processing agreement with Black Cat Syndicate.