Latest Regulatory Approvals News

Island Pharmaceuticals has submitted a detailed briefing to the FDA aiming to accelerate approval of its antiviral Galidesivir for Marburg virus under the Animal Rule, with feedback expected by November.

Synlait Milk Limited reports a modest profit turnaround in FY25 and announces a major sale of its North Island assets to Abbott, aiming to reduce debt and sharpen its focus on core operations.

Synlait has agreed to sell its North Island assets to global healthcare giant Abbott for approximately US$178 million, marking a strategic reset focused on debt reduction and operational simplification. The deal, expected to close by April 2026, positions Synlait to concentrate on its South Island operations and explore new growth avenues.

Gold Road Resources Limited shares have been suspended from the ASX following court approval of its acquisition by Gruyere Holdings Pty Ltd, marking a pivotal step in the gold miner’s corporate journey.

TMK Energy Limited has announced a significant security consolidation, merging every 55 existing securities into one, impacting shares, options, and performance rights with adjusted exercise prices.

Elanor Investors Group has obtained a crucial ASX waiver allowing a longer timeframe to issue securities tied to its $125 million recapitalisation with Rockworth Investment. This move addresses regulatory delays and aims to stabilise Elanor's balance sheet and reduce gearing.

EV Resources Limited has acquired the high-grade Milton Canyon Antimony Project in Nevada, reinforcing its strategy to supply critical minerals to the U.S. market. This move complements its existing assets in Nevada and Mexico, aligning with U.S. government priorities for secure antimony sources.

INOVIQ Limited has obtained exclusive worldwide rights to novel ovarian cancer biomarker IP from UniQuest, propelling its EXO-OC™ test closer to commercial launch. The test’s exceptional sensitivity and specificity position it as a potential breakthrough in early cancer detection.

Caravel Minerals has released its first comprehensive Sustainability Report for fiscal 2025, detailing ambitious ESG initiatives and a clear roadmap toward net-zero emissions for its Caravel Copper Project in Western Australia.

Audalia Resources is raising $500,000 through a share placement to fund critical development and regulatory steps at its Medcalf Project, aiming to advance mining permits and design.

Tamboran Resources has reported record natural gas flow rates from its Shenandoah South 2H sidetrack well and initiated the largest drilling program ever seen in the Beetaloo Basin, alongside securing key approvals for gas sales.

News Corporation has updated its dividend details for the six months ending June 2025, confirming an ordinary unfranked dividend of USD 0.10 per Class A non-voting common stock CDI, payable in both US and Australian dollars.