Latest Regulatory Clearance News

Neurizon Therapeutics has cleared a major regulatory hurdle with the FDA lifting the clinical hold on its lead drug NUZ-001 and secured a comprehensive $33 million funding package to advance its pivotal ALS trial.

Medical Developments International has posted positive operating cashflow for the first half of FY26, driven by robust growth in its flagship product Penthrox across Australia and Europe, alongside progress in paediatric approvals.

Imricor Medical Systems has achieved a major milestone with FDA clearance for its NorthStar Mapping System, the first MRI-native 3D cardiac mapping platform approved in the US. This approval positions Imricor at the forefront of MRI-guided cardiac procedures in the world’s largest electrophysiology market.

Radiopharm Theranostics has reported promising interim results from its Phase 2b trial of RAD 101, showing high concordance with MRI in brain metastases patients, while progressing multiple other clinical programs and securing a strong cash position to fund operations into 2027.

EMVision Medical Devices reports strong clinical trial progress for its portable brain scanners, backed by solid cash reserves and milestone grant funding.

Energy Fuels Inc. has announced a proposed acquisition of Australian Strategic Materials (ASM) valued at approximately A$447 million, aiming to establish a leading Western rare earths and critical minerals producer with a fully integrated supply chain.

Fatfish Group Limited has refinanced its $5.67 million debt with Arena Investors LP and secured an additional $0.15 million through new convertible notes, including a board nomination right for Arena.

BlueScope Steel has received a $30 per share takeover proposal from a consortium of SGH Limited and US-based Steel Dynamics, sparking fresh speculation about the steelmaker's future.

Memphasys has secured CE Mark approval for its Felix™ sperm selection system, enabling full commercial rollout across Europe and activating multi-year contracts worth over A$1.3 million. This milestone signals the company’s transition into a revenue-scaling phase with global growth ambitions.

RPMGlobal shareholders convened on 19 December 2025 to vote on Caterpillar's $5.00 per share acquisition proposal, with strong board support and regulatory hurdles nearing resolution.

ASPI Isotopes Inc. and Renergen Limited have received regulatory clearance to proceed with their Scheme of Arrangement, setting a detailed timetable for share suspensions, listings, and settlements complicated by cross-border processes.

Memphasys Limited’s partner International Technical Legacy has placed an early order for 500 Felix™ cartridges ahead of anticipated CE Mark approval, signalling strong clinic demand and validating the company’s direct-selling strategy in the Middle East.