Latest Regulatory Updates News

Neurizon Therapeutics has progressed its ALS treatment NUZ-001 into critical clinical trial phases, even as the FDA declines its Fast Track Designation request pending more data.

Aumake Limited has obtained a Hong Kong pharmaceutical wholesale licence, enabling it to launch up to five online over-the-counter medicine stores targeting Chinese consumers. This strategic move positions the company to tap into China’s rapidly expanding OTC market.

Imugene Limited has received positive feedback from the FDA, aligning key requirements to progress its azer-cel therapy into a pivotal clinical trial, underscoring its growing promise in blood cancer treatment.

Vitasora Health has secured AU$3.56 million from a cornerstone investor, issuing over 118 million shares, while confirming compliance with key regulatory disclosure obligations.

Viridis Mining and Minerals Limited has addressed ASX concerns following unusual trading linked to a Brazilian environmental recommendation on its Colossus Project. The company remains confident in securing the project's Preliminary License despite the non-binding recommendation.

InvestSMART Funds Management has updated the Distribution Reinvestment Plan rules for its Intelligent Investor Active ETFs, making DRP participation automatic for new investors from January 2026 unless they opt out.

Reef Casino Trust’s takeover bid by Iris Cairns Property faces a regulatory hurdle as Queensland’s Office of Liquor and Gaming Regulation delays suitability investigations, pushing the offer period beyond March 2026.

Aroa Biosurgery reported a 14% rise in product sales to NZ$44.6 million for the half-year ended September 2025, driven by strong growth in its Myriad portfolio. The company also posted a normalised EBITDA profit and reaffirmed its FY26 revenue and profit guidance.

Island Pharmaceuticals has secured FDA confirmation that its antiviral Galidesivir can proceed under the Animal Rule pathway for Marburg virus, qualifying for a lucrative Priority Review Voucher. This regulatory milestone accelerates the drug’s path to approval and potential government stockpile inclusion.

The Foreign Investment Review Board has extended its deadline for approving Mayne Pharma's acquisition by Cosette Pharmaceuticals, maintaining the current transaction timetable for now.

Hartshead Resources has been granted a two-year extension on Phase C of its UK North Sea Licence P2607, allowing more time to complete its work programme amid regulatory and supply chain delays.

The FDA's removal of the black box warning on hormone replacement therapies marks a pivotal shift for Mayne Pharma, potentially unlocking new market opportunities and reshaping women’s health treatment.