Latest Regulatory Clearance News

PainChek Ltd has secured FDA De Novo clearance for its Adult App, marking a pivotal entry into the US long-term care market and setting the stage for global expansion including its Infant App.

Invictus Energy updates progress on its AMOG joint venture with Al Mansour Holdings, revealing ongoing negotiations for a significant Qatari ownership stake and deferral of a key placement settlement.

Infomedia Ltd has announced a fully franked special dividend of 2.9 cents per share, payable in late November, linked to its pending acquisition by McQueen BidCo Pty Ltd.

Helloworld Travel Limited has made a non-binding indicative all-cash offer to acquire the remaining shares of Webjet Group at A$0.90 per share, signaling a potential major consolidation in the online travel sector.

RPMGlobal shareholders are set to vote on Caterpillar’s $5.00 per share acquisition proposal following Federal Court approval to convene a Scheme Meeting. The Independent Expert deems the offer fair and reasonable, with the RPM Board unanimously backing the deal.

Infomedia Limited has secured Foreign Investment Review Board approval for its proposed acquisition by TPG Capital-backed McQueen BidCo, marking a key regulatory milestone. The Infomedia Board continues to recommend shareholder support ahead of upcoming votes.

Anteris Technologies has gained FDA approval to start patient recruitment in the US for its pivotal PARADIGM Trial, following initial European regulatory success. The company advances manufacturing and clinical readiness as it pushes toward key regulatory milestones.

Anteris Technologies Global Corp. reported a $22.2 million loss in Q3 2025 while progressing its DurAVR Transcatheter Heart Valve pivotal trial following key regulatory approvals. The company bolstered its cash position with a $25.2 million private placement post-quarter.

Regis Resources has significantly increased Ore Reserves at its Buckingham-Wellington pits, extending Duketon North’s mine life and boosting production prospects with minimal new capital investment.

Seven West Media shareholders are preparing to vote on a scheme of arrangement for acquisition by Southern Cross Media Group, with the Seven board unanimously recommending approval. The merger promises significant cost synergies and a stronger combined media platform.

Global Uranium and Enrichment Limited has entered a new funding agreement with Summit Strategies LLC, raising an additional A$2.5 million through convertible notes to support its ongoing operations and merger obligations with Snow Lake Resources.

Memphasys Limited has successfully raised over $1.1 million through a pro-rata entitlement offer to accelerate the commercialisation of its innovative Felix™ sperm selection system, targeting key regulatory approvals and market expansion.