Latest Regulatory Affairs News

Amplia Therapeutics reports strong progress in its pancreatic cancer drug development, completing the ACCENT trial recruitment ahead of schedule and initiating a new US trial, while managing a $6.57 million loss for FY25.

Equatorial Resources Limited has refuted media reports claiming the Guinea government cancelled its Nimba Alliance iron ore exploration permits, stating no formal communication has been received and that it is actively seeking clarity.

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.