Latest Regulatory Approvals News

PYC Therapeutics reports sustained vision improvements in patients with Retinitis Pigmentosa type 11 treated with VP-001, showing promising safety and efficacy up to 18 months. The company plans to engage the FDA in early 2026 to finalize pivotal trial design.

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.

Synlait Milk Limited has temporarily expanded its banking facilities by NZ$50 million to manage ongoing cost impacts from earlier manufacturing challenges, while preparing to reduce debt through a major asset sale.

Island Pharmaceuticals will host a webinar to discuss the FDA's feedback on the clinical development and regulatory approval of its antiviral drug Galidesivir, including key considerations under the FDA's Animal Rule and Priority Review Voucher eligibility.

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.

Evergreen Lithium has formalised a binding option to acquire up to 100% of the Mt Monger Gold Project in Western Australia, reinforcing its strategic expansion in the prolific Goldfields region.

The ACCC has decided not to oppose Southern Cross Media’s proposed acquisition of Seven West Media, citing limited competition concerns amid evolving digital media landscapes.

The ACCC has decided not to oppose Southern Cross Media’s proposed acquisition of Seven West Media, finding limited competition concerns amid evolving digital media landscapes.

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.

Superior Resources Limited has lodged a transaction specific prospectus to offer 1,000 new shares at $0.01 each, enabling previously issued shares to be sold without further disclosure. The move addresses regulatory compliance while raising minimal funds.

Star Minerals has inked a pivotal Right to Mine Agreement with MEGA Resources and Bain Global Resources, unlocking $20 million in funding and operational support for its Tumblegum South Gold Project, aiming for production in early 2026.