Latest Regulatory Milestones 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.

Manuka Resources has gained approval for a secondary listing on the New Zealand Stock Exchange, enhancing trading access for local shareholders and supporting its strategic growth in critical and precious metals projects across New Zealand and 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.

Vulcan Energy has inked a €110 million fixed-price contract to build a geothermal power plant in Germany, a cornerstone for its Phase One Lionheart Project that aims to supply sustainable lithium and renewable energy for half a million electric vehicles annually.

American Uranium has received regulatory approval to commence a significant drilling campaign at its Lo Herma uranium project in Wyoming, aiming to boost its resource base amid a growing US nuclear revival.

Medallion Metals has successfully completed the public comment phase under the EPBC Act for its Ravensthorpe Gold Project, advancing a critical regulatory milestone with no objections received. The company aims to submit final documentation in October and expects a decision before year-end, paving the way for its sulphide development strategy.

Race Oncology has secured Investigational New Drug approval from South Korea’s regulatory authority, enabling Phase 1 clinical trials of RC220 in combination with doxorubicin for solid tumour patients across four Korean sites.

Vonex Limited shareholders have overwhelmingly approved Maxo Telecommunications’ acquisition scheme, setting the stage for a court decision that could delist Vonex from the ASX.

Arovella Therapeutics has received a $3.21 million R&D tax incentive refund, bolstering its financial position as it prepares to initiate first-in-human trials for its lead cell therapy, ALA-101.

INOVIQ Limited has demonstrated that its CAR-NK-exosome therapy kills over 90% of triple-negative breast cancer cells within 10 hours in laboratory tests, validating its potential as a next-generation cancer treatment.

Echo IQ has completed its presentation to the CPT Editorial Panel for a Category III CPT code for EchoSolv AS, with a decision expected from the American Medical Association in the coming weeks. Meanwhile, the company is advancing US deployments and FDA clearance efforts.