Latest Regulatory Affairs News

Dimerix Limited’s ACTION3 Phase 3 trial for DMX-200 in treating FSGS kidney disease has passed its sixth independent safety review with no concerns, reinforcing the drug’s promising safety profile.

Echo IQ’s application for a key US procedural code was rejected but the company plans a swift resubmission, maintaining confidence in its US commercial rollout.

Avecho Biotechnology has expanded its pivotal Phase III clinical trial for a CBD insomnia treatment by adding new recruitment sites and partnering with pharmaceutical giant Sandoz to boost patient enrolment and regulatory progress.

LTR Pharma has expanded patient access to its fast-acting erectile dysfunction treatment SPONTAN by partnering with TerryWhite Chemmart’s extensive pharmacy network, marking a significant step in its commercial rollout and regulatory strategy.

Cynata Therapeutics confirms that the recent FDA orphan-drug exclusivity granted to Ryoncil® will not block approval of its CYP-001 therapy, highlighting key differences in drug composition and patient indications.

An application to the Takeovers Panel challenges Pact Group Holdings’ planned ASX delisting, citing concerns over shareholder disadvantage and selective disclosure.

AVITA Medical reveals a bold expansion plan targeting a $3.5 billion U.S. acute wound care market by 2025, driven by a multi-product portfolio and sustained revenue growth.

PointsBet Holdings Limited has announced a scheme meeting for shareholders to vote on its proposed $1.06 per share acquisition by MIXI Australia, with an independent expert deeming the offer fair and reasonable amid a competing bid from betr Entertainment.

Alterity Therapeutics is set to present compelling Phase 2 clinical trial results for ATH434 at the 2025 International Multiple System Atrophy Congress, highlighting slowed disease progression and biomarker engagement in MSA patients.

A landmark High Court ruling in South Africa exempts upstream petroleum activities from the Gas Act, easing regulatory burdens for companies like Renergen and Tetra4.

Neurotech International has reported excellent safety and tolerability for its lead drug NTI164 in 28-day GLP toxicology studies, paving the way for regulatory submissions and longer-term clinical development.

Bio-Gene Technology Limited has raised $2.1 million through a placement and launched a Share Purchase Plan to fund critical safety studies for its flagship insecticide Flavocide®, alongside development of Qcide and strategic initiatives.