Latest Regulatory Clearance News

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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.
Ada Torres
Ada Torres
30 Jan 2026
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.
Ada Torres
Ada Torres
30 Jan 2026
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.
Ada Torres
Ada Torres
29 Jan 2026
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.
Ada Torres
Ada Torres
28 Jan 2026
EMVision Medical Devices reports strong clinical trial progress for its portable brain scanners, backed by solid cash reserves and milestone grant funding.
Ada Torres
Ada Torres
28 Jan 2026
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.
Maxwell Dee
Maxwell Dee
21 Jan 2026
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.
Sophie Babbage
Sophie Babbage
8 Jan 2026
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.
Maxwell Dee
Maxwell Dee
5 Jan 2026
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.
Ada Torres
Ada Torres
29 Dec 2025
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.
Sophie Babbage
Sophie Babbage
19 Dec 2025
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.
Maxwell Dee
Maxwell Dee
18 Dec 2025
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.
Ada Torres
Ada Torres
18 Dec 2025