Latest Regulatory Milestones News

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.

Island Pharmaceuticals has cleared a major regulatory hurdle with the US FDA, confirming a clinical development path for its antiviral Galidesivir under the Animal Rule. Backed by a $9 million capital raise and strategic partnerships, the company is poised for potential US government procurement and biodefence market entry.

Brazilian Rare Earths (ASX: BRE) has reported substantial expansion of its Monte Alto rare earth project with ultra high-grade drilling results and validated low-temperature processing delivering 97% recovery. The company also secured a Trial Mining Licence enabling early production and bulk shipments.

Alterity Therapeutics has secured FDA alignment on the chemistry and manufacturing controls for its ATH434 Phase 3 trial in Multiple System Atrophy, marking a pivotal regulatory milestone ahead of the planned mid-2026 End-of-Phase 2 meeting.

Imricor Medical Systems updates its SEC Form 10 with minor SEC-driven revisions as it pushes forward with FDA clearances and clinical trials, reporting a $25.3 million net loss in 2025 amid early-stage commercialisation.