Latest Regulatory Milestones News

Anteris Technologies has gained U.S. Medicare reimbursement eligibility for its pivotal PARADIGM Trial, clearing a key hurdle for clinical site activation and accelerating its transcatheter heart valve study.

Lake Resources made solid progress on the Exploitation Environmental Impact Assessment for its Kachi Lithium Brine Project, targeting approval in Q3 2026, while maintaining strong liquidity and strategic partnerships.

Atomo Diagnostics capitalises on Lumos Diagnostics’ FebriDx FDA CLIA waiver with over $2 million in new sales orders and a $3 million capital raise, expanding its global footprint and product pipeline.

Amplia Therapeutics reported mature ACCENT trial data showing improved survival and multiple complete responses with narmafotinib, alongside a GMP production milestone and CFO appointment.

OncoSil Medical reported a 60% year-on-year increase in dose sales in Q3 FY26, boosted by expanding treatment centres and advancing clinical trials, while cost-cutting and a new manufacturing facility aim to underpin growth.

Algorae Pharmaceuticals has struck an exclusive commercial and licensing agreement with global pharma Zydus Lifesciences to bring 10 injectable, oral, and specialty medicines to Australia and New Zealand, pending regulatory approvals.

Cleo Diagnostics has kicked off a staged manufacturing program with Bio-Techne to produce ovarian cancer test kits, moving from clinical sample collection to analytical validation and FDA submission preparation.

Singular Health boosted its US presence by deploying 500 additional 3DICOM MD® licenses to Provider Network Solutions, securing FDA 510(k) clearance for its cloud platform, and launching education pilots with Miami-Dade schools and Florida International University.

Vitrafy Life Sciences completed Phase II of its U.S. Military platelet cryopreservation study with strong results for a simplified no-wash process, accelerating commercial interest and progressing FDA device registration despite manufacturing delays.

Riversgold has kicked off a focused nine-day diamond drilling campaign at its Northern Zone Gold Project near Kalgoorlie to gather essential rock strength data for pit design, as it nears a key mining lease grant and development partnership with MEGA Resources.

Bio-Gene Technology is progressing critical toxicology studies for Flavocide with a targeted APVMA submission in March 2027, while forging a strategic partnership to launch Qcide insecticides in Japan by late 2026.

PYC Therapeutics has gained Orphan Drug Designation from the European Medicines Agency for its VP-001 candidate targeting Retinitis Pigmentosa type 11, enhancing its regulatory and commercial pathway in Europe.