Latest Fda News

Actinogen Medical advances its XanaMIA phase 2b/3 Alzheimer’s trial with faster patient enrolment and expands clinical sites, while achieving a pivotal FDA meeting outcome for its depression program. The company maintains a strong cash position, supporting ongoing development and commercialization efforts.

Syntara Limited reports significant clinical progress with its lead myelofibrosis drug SNT-5505 and launches a new trial for its next-generation anti-fibrotic skin treatment, supported by a solid $18 million cash reserve.

Imugene Limited reports encouraging Phase 1b results for azer-cel in lymphoma, secures FDA Fast Track status, and strengthens patent portfolio while raising A$20 million to fuel ongoing immuno-oncology programs.

PainChek Limited reports strong progress toward FDA De Novo clearance for US market entry, launches its Infant App in Australia, and achieves robust global licence growth with a 30% year-on-year revenue increase.

ImpediMed Limited reported a record A$3.4 million revenue in Q3 FY25, bolstered by a surge in Annual Recurring Revenue and a strategic sales leadership change aimed at accelerating SOZO platform adoption.

Amplia Therapeutics has completed recruitment early for its Phase 2a ACCENT trial in advanced pancreatic cancer, reporting encouraging interim results and advancing a second trial with FDA-backed protocol changes.

Ecofibre Limited reported a $2.2 million operating cash outflow in 3Q25 with total cash at $1.3 million, highlighting mixed progress across its business units and a pressing need to monetise assets to sustain operations.

Control Bionics reports its strongest US revenue in years alongside Australia’s best quarter since 2022, propelled by new product launches and strategic investments.

Argenica Therapeutics has completed patient dosing in its Phase 2 trial of ARG-007 for acute ischaemic stroke, with topline data expected in Q3 2025. The company also plans to submit its Investigational New Drug application and Fast Track request to the FDA imminently.

EMVision Medical Devices has commenced the pivotal clinical trial for its emu™ bedside brain scanner aimed at FDA clearance, while advancing its First Responder device through successful aeromedical testing and ethics approvals. The company maintains strong cash reserves of $12.58 million to support ongoing innovation and clinical activities.

Universal Biosensors reported a 28% increase in customer receipts to $1.6 million for Q1 2025, alongside improved cash flow and plans for a new product launch later this year.

Zelira Therapeutics has enhanced its financial flexibility through a $1.15 million R&D tax refund and a $1 million At-the-Market equity facility, while progressing FDA trial preparations for its HOPE® 1 autism treatment.