Latest Regulatory Affairs News

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.

Alterity Therapeutics has secured FDA Fast Track designation for ATH434, its lead candidate for treating Multiple System Atrophy, potentially speeding up regulatory review and bringing hope to patients with this rare neurodegenerative disorder.

Immutep’s combination of eftilagimod alfa (efti) and KEYTRUDA® delivers a striking 17.6-month median overall survival in head and neck cancer patients with low PD-L1 expression, a group with limited treatment options.

Cardiex reports strong early sales momentum for its CONNEQT Pulse device with approximately 3,000 units sold or contracted since its mid-January launch, supported by innovative app features and operational efficiencies. Despite regulatory delays in the US pharma sector and tariff challenges, the company is positioned for scalable growth and category leadership in preventative cardiovascular care.

Mesoblast has commercially launched Ryoncil in the US for pediatric acute GVHD, backed by a strong cash position and advancing multiple cell therapy programs.