Latest Regulatory Affairs News

Recce Pharmaceuticals has initiated patient dosing in its pivotal Phase 3 trial for diabetic foot infections in Indonesia, targeting a significant market with high diabetes prevalence. Interim results expected in early 2026 could accelerate regulatory approval and commercial launch.

Island Pharmaceuticals has won a crucial FDA Type C meeting to discuss fast-tracking its antiviral Galidesivir for Marburg virus treatment, with written feedback expected by November.

Neurizon Therapeutics has raised $5 million through an institutional placement to advance its lead ALS drug candidate NUZ-001 into a pivotal clinical trial, pending FDA clearance. The capital injection also supports manufacturing and pre-clinical development efforts.

Renergen Limited and ASP Isotopes Inc. have proactively extended the deadline to fulfill outstanding conditions for their Scheme of Arrangement offer to 28 November 2025, following key regulatory approvals and ongoing collaboration.

Cleo Diagnostics has received encouraging feedback from the U.S. FDA on its ovarian cancer pre-surgical triage test, reinforcing its clinical trial design and regulatory strategy ahead of a critical 510(k) submission.

Actinogen Medical has reached a pivotal agreement with the US FDA outlining the regulatory and clinical trial requirements for Xanamem’s approval in Alzheimer’s disease, setting a clear path toward a US marketing application.

A shareholder has lodged a formal application with the Takeovers Panel challenging Emu NL’s recent entitlement offer and associated loan facility, raising concerns over board control and transparency ahead of a critical EGM.

Alterity Therapeutics has raised A$20 million through a strategic placement to advance its promising ATH434 treatment for Multiple System Atrophy, backed by encouraging Phase 2 trial results. The capital injection strengthens the company’s balance sheet as it prepares for regulatory discussions with the FDA.

Mayne Pharma has publicly refuted recent media claims about plans to close its Salisbury manufacturing site, clarifying its position amid ongoing regulatory scrutiny of its Scheme transaction with Cosette.

Lumos Diagnostics has secured a significant follow-on contract with Aptatek Biosciences to push forward the development of an innovative in-home monitoring device for Phenylketonuria (PKU), a rare genetic disorder. This next phase aims to bring the FDA Breakthrough Device-designated PheCheck™ closer to clinical trials and commercial readiness.

Island Pharmaceuticals has formally requested a Type C meeting with the US FDA to discuss accelerating approval of its antiviral Galidesivir for Marburg virus using the Animal Rule pathway.

Neurotech International reported a 23% revenue drop and a doubling of its net loss to $10.6 million for FY25, driven by reduced R&D grants and high development costs. Despite financial pressures, the company marked significant clinical and regulatory progress for its NTI164 cannabinoid therapy.