Latest Regulatory Milestones News

Island Pharmaceuticals has secured FDA confirmation that its antiviral Galidesivir can proceed under the Animal Rule pathway for Marburg virus, qualifying for a lucrative Priority Review Voucher. This regulatory milestone accelerates the drug’s path to approval and potential government stockpile inclusion.

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.

Biotron Limited’s lead HBV drug BIT-HBV001 demonstrates superior antiviral activity and synergy with the current standard treatment Tenofovir in preclinical models, advancing hopes for a more effective Hepatitis B therapy.

Bio-Gene Technology’s natural insecticide Qcide® has earned organic listing status from the US Organic Materials Review Institute, marking a pivotal step for its entry into the organic pest control market.

The ACCC has given informal clearance for the merger between Southern Cross Media Group and Seven West Media, marking a key regulatory milestone. The deal still awaits shareholder and ACMA approvals before completion.

The Australian Competition and Consumer Commission has given the green light to Southern Cross Media’s proposed acquisition of Seven West Media, marking a significant regulatory milestone in the evolving Australian media landscape.

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.

Neurotech International has received a $4.73 million R&D tax incentive refund, reinforcing its clinical development efforts in paediatric neurological disorders. The funds will support ongoing trials and working capital needs.

Marimaca Copper's Chilean subsidiary has obtained formal environmental approval for its Marimaca Oxide Project, clearing a critical hurdle toward construction readiness in the second half of 2026. This milestone follows years of environmental and social groundwork and sets the stage for the next permitting phase.

MA Financial Group advances exclusive due diligence on a major Queensland retail asset and prepares a new ASX-listed credit notes offer, signaling strategic growth moves.

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.

Mandrake Resources has signed a term sheet with DISA Technologies to explore recovering uranium and critical minerals from abandoned mine waste in Utah, leveraging a unique US regulatory license and strong government backing.