Latest Fda News

Optiscan Imaging Ltd secured $17.75 million in a fully underwritten equity raise, fueling clinical studies and regulatory preparations for its innovative medical imaging devices. The company also reported progress in international trials and strengthened its cash position to nearly $20 million.

Arovella Therapeutics has secured encouraging feedback from the US FDA on reagent testing for its CAR-iNKT cell therapy, setting the stage for an IND filing this quarter and clinical trials in early 2026.

Syntara Limited reports encouraging Phase 2a results for amsulostat in myelofibrosis, with significant symptom relief and spleen volume reduction sustained over 12 months, alongside new clinical trial initiations and a solid cash position.

EMVision Medical Devices has expanded its pivotal clinical trial sites, secured a $3 million government grant, and raised $14 million through placement and share purchase plan, positioning itself strongly for upcoming regulatory submissions and commercialisation.

Cambium Bio has locked in a significant R&D tax rebate and forged three strategic partnerships, underpinning its Phase 3 clinical trials for its lead ophthalmology biologic. The company’s recent capital raise further strengthens its runway as it prepares for pivotal trial milestones.

Zelira Therapeutics has made significant progress in its HOPE 1 clinical trial program, completing a key FDA submission and securing a $650,000 non-dilutive R&D loan facility to support ongoing development and working capital needs.

PYC Therapeutics has reported significant progress across its four RNA therapeutic programs targeting genetic diseases, alongside a strong cash runway supporting ongoing development.

Artrya Limited has secured FDA clearance for its Salix Coronary Plaque module and raised $80 million to fuel its U.S. commercial expansion, marking a pivotal step in its transition from development to revenue generation.

Tetratherix reports encouraging safety and stability results from its Tutelix hydrogel spacer trial, initiates stage 2 recruitment, and secures a $3.3 million government grant to boost manufacturing capacity and R&D.

AdAlta Limited has fully repaid its remaining NLSC investment in cash, ending its obligation to issue further shares and positioning itself for private capital raises to advance its CAR-T therapies.

Vitasora Health is set to scale its AI-powered chronic care services from Hawaii to 10-15 US states, leveraging a new partnership with Privia Health following Evolent Care Partners' divestiture. This expansion targets up to 30,000 patients and promises significant revenue growth in 2026.

Actinogen Medical has fast-tracked enrolment in its pivotal Alzheimer’s trial, secured a clear FDA regulatory path, and strengthened its financial position with funding extending its runway to mid-2026.