Latest Us Fda News

Clarity Pharmaceuticals confirms continuation of its SECuRE Phase II trial for Cu-SAR-bisPSMA without protocol changes, reporting encouraging safety and efficacy data in metastatic prostate cancer patients.

Recce Pharmaceuticals has received a $5.3 million R&D tax rebate from the Australian Taxation Office, providing a significant cash injection to support its innovative synthetic anti-infective drug development programs.

Neuren Pharmaceuticals’ partner Acadia projects DAYBUE sales to reach around US$700 million by 2028, driven by US market expansion and international approvals. The launch of a new formulation and ongoing clinical trials in Japan underpin this optimistic outlook.

The Calmer Co. International Limited has reported its highest ever monthly sales of $910,767 in December 2025, driven by strong wholesale growth and expanding US market presence.

Pharmaceutical manufacturer ANO has been hit with a US FDA Import Alert, joining several Australian peers amid wider regulatory tensions. The company is mobilising expert consultants and preparing a petition to lift the alert within weeks.

Neuren Pharmaceuticals has published promising Phase 2 trial results for NNZ-2591 in Phelan-McDermid syndrome, underpinning its ongoing Phase 3 Koala trial recruiting in the US.

Mayne Pharma reports mixed early FY26 results with strong prescription growth in Women’s Health and improved Dermatology margins, while strategic reviews and litigation loom.

Imricor Medical Systems has secured Charité University Hospital in Berlin as the second global site for its VISABL-VT clinical trial, marking a significant milestone in real-time MRI-guided cardiac ablation technology.

Recce Pharmaceuticals has won a significant Australian Government R&D tax incentive, unlocking up to A$85 million for its synthetic anti-infective programs worldwide, including a pivotal Phase 3 clinical trial.

Prescient Therapeutics has secured European authorization to initiate a Phase 2a clinical trial of its novel cancer drug PTX-100 for relapsed/refractory Cutaneous T-cell Lymphoma, enabling trial site activation in Italy.

Cynata Therapeutics has finalised patient enrolment in its pivotal Phase 2 trial of CYP-001 for acute graft versus host disease, setting the stage for critical data due mid-2026.

Neuren Pharmaceuticals’ partner Acadia secures FDA approval for DAYBUE STIX, a new powder formulation of trofinetide offering greater flexibility for Rett syndrome patients. This milestone expands treatment options and sets the stage for increased royalty revenue in 2026.