Latest Regulatory Updates News

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AdAlta Limited has aligned its AdCella manufacturing strategy with new US FDA guidelines, made a significant milestone payment to Shanghai Cell Therapy Group, and secured an additional R&D tax rebate, marking key progress in its cellular immunotherapy pipeline.
Ada Torres
Ada Torres
21 Jan 2026
MRG Metals has completed its acquisition of the Garies Rare Earth Project, adding a high-grade, magnet-rich rare earth asset in South Africa to its portfolio. This move significantly boosts the company’s exposure to critical minerals essential for emerging technologies.
Maxwell Dee
Maxwell Dee
19 Jan 2026
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.
Ada Torres
Ada Torres
2 Jan 2026
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.
Ada Torres
Ada Torres
18 Dec 2025
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.
Ada Torres
Ada Torres
8 Dec 2025
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.
Ada Torres
Ada Torres
2 Dec 2025
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.
Maxwell Dee
Maxwell Dee
1 Dec 2025
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.
Claire Turing
Claire Turing
1 Dec 2025
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.
Victor Sage
Victor Sage
25 Nov 2025
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.
Ada Torres
Ada Torres
25 Nov 2025
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.
Victor Sage
Victor Sage
17 Nov 2025
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.
Ada Torres
Ada Torres
13 Nov 2025