Latest Regulatory Updates News

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.

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.

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.

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.

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.

DroneShield Limited has retracted its recent announcement of $7.6 million in new U.S. Government orders, clarifying these were reissued contracts rather than fresh deals. The company is addressing the administrative error to prevent future confusion.

Aguia Resources advances its phosphate operations in Brazil with new funding and plant upgrades, while a management overhaul in Colombia reveals a significant gold discovery at Santa Barbara.

Dome Gold Mines reports steady progress on its Sigatoka heavy mineral sands project despite delays in a government-led river desilting program, while exploring funding options for its Nadrau copper-gold project in Fiji.

Neuren Pharmaceuticals has secured FDA Fast Track designation for its drug NNZ-2591 targeting Phelan-McDermid syndrome, accelerating its path through clinical development. This milestone underscores the urgent need for treatments in rare neurodevelopmental disorders.

Challenger Limited reported a solid 4% increase in total Life sales to $2.5 billion in Q1 FY26, buoyed by strong annuity sales and strategic partnerships. The company reaffirmed its FY26 earnings guidance while highlighting upcoming regulatory changes expected to benefit the sector.