Latest Regulatory Approvals News

Gyder Surgical, backed by Hydrix Ventures, has secured FDA 510(k) clearance for its innovative GYDER Hip System, opening the door to the lucrative U.S. market and increasing Hydrix’s investment value.

TEAMINVEST PRIVATE GROUP LIMITED has announced a fully franked ordinary dividend of AUD 0.015 per share for the six months ending December 31, 2024, payable in March 2025.

Wellnex Life Limited has announced a non-renounceable entitlement offer to raise approximately $22.1 million at $0.65 per share, supporting its planned AIM listing and strategic growth initiatives.

Wellnex Life Limited has initiated a $22.1 million entitlement offer priced at $0.65 per share, coinciding with its proposed dual listing on the London Stock Exchange's AIM market, driven by strong UK institutional interest.

BTC Health has transformed its decade-long license agreement with Arna Pharma into an indefinite partnership, gaining royalties from Singapore and Malaysia sales and first rights to new pharmaceutical products in Australia and New Zealand.

S2 Resources has initiated its first aircore drilling campaign at the Yeungroon project, aiming to delineate gold-arsenic hotspots along the extensive O'Connors trend. Results are expected by April 2025, potentially unlocking new opportunities in Victoria’s historic goldfields.

Golden Horse Minerals has reported compelling soil geochemistry results at its Southern Cross Project, revealing multiple significant gold anomalies and securing a strategic mining lease to bolster exploration efforts.

VIP Gloves Limited has obtained a short-term interest-free loan of approximately AUD$1 million ahead of a planned share placement, as it faces potential delisting from the ASX pending a critical reinstatement decision.

PYC Therapeutics has secured regulatory approval to initiate human trials of PYC-003, a novel drug candidate targeting the root cause of Polycystic Kidney Disease (PKD). Initial safety and efficacy data are expected within 2025, marking a critical step in addressing a disease affecting millions worldwide.

Radiopharm Theranostics' RAD 101 radiotracer demonstrates high sensitivity in detecting brain metastases using a novel PET-mpMRI approach, with a Phase 2b trial now recruiting in the US.

Black Dragon Gold has applied for its Salave Gold Project to be designated a Strategic Investment Project under new regional legislation in Asturias, aiming to fast-track development and boost local economic benefits.

Moho Resources has agreed to sell its Empress Springs Project in Western Queensland for $1.258 million, including deferred payments and a retained royalty, as it refocuses its portfolio.