Arovella Therapeutics (ASX:ALA) has entered a pivotal new phase of development after securing US Food and Drug Administration acceptance of its Investigational New Drug application for ALA-101.

Ovarian cancer remains notoriously difficult to diagnose at an early stage, with symptoms that are often vague, non-specific and easily mistaken for less serious conditions.

Without whole-of-government action, warned AusBiotech Chief Executive Officer Rebekah Cassidy, Australia may continue to lose ground to countries that have already identified life sciences as a cornerstone of economic growth and national resilience.

Australia’s advanced therapies sector is set to gain new momentum with the formal establishment of a joint Advanced Therapies Advisory Group by AusBiotech and Medicines Australia, bringing together senior leaders from biotechnology, pharmaceuticals, healthcare, research, and manufacturing to help shape the future of cell and gene therapies nationwide.

Australian company PYC Therapeutics has announced a capital raising of up to $653 million, a scale of funding rarely seen on the Australian Securities Exchange and one that places the Perth-founded biotech among a small group of local life sciences firms able to attract global capital at this magnitude.

As antimicrobial resistance (AMR) becomes one of the most serious threats to global health and economic stability, Australian biotechnology company Lixa has taken a decisive step to confront this challenge.

Cyclopharm (ASX:CYC) has capped off 2025 with record operating revenue, marking a pivotal year in the company’s transformation as the United States rapidly becomes its most important market.

Genetic Signatures has appointed experienced life sciences executive Maria Halasz as its new Chief Executive Officer, marking a leadership transition as the molecular diagnostics company moves into its next phase of international growth.

Imagion Biosystems (ASX:IBX) has announced that it has lodged an Investigational New Drug (IND) application with the U.S. Food and Drug Administration for its MagSense targeted imaging agent.

Argenica Managing Director Dr Liz Dallimore described the decision as a key milestone in the company’s global regulatory strategy, noting that it provides clarity and certainty as ARG-007 progresses through development.

Commenting on the announcement, Recce Pharmaceuticals’ Chief Executive Officer, James Graham, said the company was proud to deepen its engagement with the U.S. Army.

The new Investor Readiness Panel will support AusBiotech by providing stage-appropriate, non-binding guidance on a company’s readiness to engage with investors.

Arovella Therapeutics (ASX:ALA) has secured acceptance from the U.S. Food and Drug Administration for its investigational new drug application for ALA-101.

Patrys (ASX:PAB) has completed the acquisition of Reliis, marking a significant milestone in the company’s strategy to broaden its clinical-stage therapeutic pipeline with a differentiated, lower-risk asset.

Cyclopharm (ASX:CYC) has taken a significant step toward expanding the clinical and commercial scope of its Technegas platform, announcing a new clinical research collaboration to address one of the largest unmet needs in global respiratory medicine: advanced chronic obstructive pulmonary disease.

Cartherics has strengthened its global intellectual property position with the granting of a key patent in China, reinforcing the foundations of its lead cell therapy program and expanding its reach into one of the world’s fastest-growing oncology markets.

Paradigm Biopharmaceuticals (ASX:PAR) has reached an important scientific milestone with the peer-reviewed publication of results from its Phase 2 biomarker study investigating injectable pentosan polysulfate sodium (iPPS) in patients with moderate to severe knee osteoarthritis.