Latest Regulatory Review News

Echo IQ has partnered with Mayo Clinic to assess its AI platform's ability to predict heart failure risk in patients undergoing cancer therapy, targeting the growing cardio-oncology sector.

The ACCC has moved Peter Warren Automotive’s acquisition of Wakeling Automotive’s 30 dealership sites into a Phase 2 review amid concerns it could dominate Sydney’s Macarthur region new car market, controlling 25 of 33 dealerships locally.

Bubs Australia expects FY26 revenue between $105 million and $115 million, with underlying EBITDA forecast at $4 million to $8 million despite external challenges including regulatory delays and increased air freight costs.

Chorus has reported a rise in its fibre regulated asset base to NZD 6 billion for 2025, alongside a significant NZD 101 million under-earn on its maximum allowable revenue, resulting in a NZD 76.3 million wash-up balance to be carried into the next regulatory period.

Recce Pharmaceuticals has signed a non-binding term sheet with a major Middle Eastern pharma player for exclusive rights to commercialise its R327 Topical Gel across the MENA region, targeting a high diabetes burden market.

Argenica Therapeutics has passed a critical FDA genotoxicity test for its stroke drug ARG-007, advancing its IND application and edging closer to Phase 2b clinical trials in the US and Australia.

OncoSil Medical has clinched TGA approval for its OncoSil™ device, the first Class III medical device targeting pancreatic tumours in Australia, paving the way for local commercialisation and enhanced patient access.

The Australian Treasurer has mandated the disposal of over 1.6 billion shares held by foreign entities in Northern Minerals, intensifying regulatory scrutiny of foreign ownership in this critical rare earths company.

Singapore’s telecom regulator has paused its assessment of Tuas Limited’s acquisition of M1 Limited amid concerns over unauthorized spectrum use by Simba, a related entity. This regulatory hurdle casts uncertainty on the transaction’s imminent completion.

Optiscan Imaging has submitted its FDA dossier for InSpecta®, marking a crucial step toward US veterinary market entry, while progressing clinical studies for InVue® and InForm® ahead of further FDA submissions in 2026.

CurveBeam AI reported stable device orders but faces regulatory delays for FDA and China clearances, while securing a A$4 million investment from WEGO Orthopaedics and advancing clinical collaborations with robotic surgery systems.

Rakon Limited has swung back to profit in FY26, reporting a 24% revenue lift and doubling EBITDA, while Bourns' takeover offer edges closer to completion with 85% shareholder acceptance and pending French regulatory approval.