Latest Regulatory Approval News

Cleo Diagnostics has successfully completed Stage 1 of the Medical Device Single Audit Program, marking a significant step toward FDA submission and global commercialisation of its ovarian cancer test.

OncoSil Medical reports a remarkable 917% increase in quarterly cash receipts alongside promising clinical trial results and key European market entries, signaling robust momentum in its pancreatic cancer treatment rollout.

Vintage Energy reported a 24% drop in quarterly sales revenue to $0.9 million alongside a 20% production decline, while initiating a Production Uplift Program targeting its Southern Flank gas fields and maintaining steady 2P reserves at 12.5 MMboe.

Terragen Holdings expands its probiotic product range into beef and lamb feedlots, secures key international approvals, and progresses large-scale trials while maintaining a $3 million cash reserve.

Alliance Nickel’s September 2025 quarterly report highlights a robust Definitive Feasibility Study for its NiWest Nickel-Cobalt Project, alongside ongoing strategic partnership talks and solid financial footing.

Temas Resources has completed its acquisition of ORF Technologies, gaining full ownership of the patented Regenerative Chloride Leach (RCL) technology that promises significant cost and environmental advantages in critical metals processing.

Hillgrove Resources has reported a substantial increase in its 2025 Mineral Resource and Ore Reserve Estimates at the Kanmantoo Copper Mine, with a 43% rise in reserve tonnes and a 33% increase in contained copper metal, significantly extending the mine's operational life.

Medallion Metals has executed a binding agreement to acquire the Forrestania Nickel Operation from IGO, expanded its Ravensthorpe gold-copper resource to nearly 1 million ounces gold equivalent, and secured a $50 million prepayment facility with Trafigura to advance project development.

NeuroScientific Biopharmaceuticals has secured regulatory approval for initial patient treatments under its Special Access Program for StemSmart™ in Crohn’s disease, alongside key executive appointments and a manufacturing partnership to support upcoming clinical trials.

CurveBeam AI has inked a decade-long exclusive partnership with a major Chinese medical device joint venture, unlocking rapid market entry and a $10 million capital boost to expand its weight bearing CT and AI solutions across Greater China.

Ampol Limited reported a robust third quarter in 2025 with refinery margins hitting a notable high, offsetting volume declines and setting the stage for strategic growth.

S2 Resources has agreed to sell its Fosterville exploration licence to Agnico Eagle for A$17 million and raised an additional A$3 million through a strategic share placement, positioning the company strongly for future exploration.