Latest Fda News

Nanosonics reported steady FY26 revenue growth driven by its trophon disinfection platform and advanced the CORIS System towards commercial launch, backed by a strong balance sheet and a new $40 million share buyback.

EMVision Medical Devices has made significant strides in its emu™ bedside scanner pivotal trial and First Responder program, boosting FY26 revenue by 57% while trimming its net loss by 15%.

AdAlta Limited (ASX:1AD) has progressed its ‘East to West’ cellular immunotherapy strategy by securing its first CAR-T asset, advancing Australian manufacturing and US FDA regulatory engagement, while raising A$5.3 million in FY2026 and reporting a net loss of $4.68 million.

Prescient Therapeutics cut its net loss by 4.4% to $7 million in FY26 while expanding its PTX-100 Phase 2a trial across three continents and securing key regulatory designations in Europe and the US.

Island Pharmaceuticals has commissioned a second manufacturing run of its antiviral Galidesivir, aiming to stockpile up to 800 treatment courses by late 2026 to support rapid response to the fast-spreading Bundibugyo Ebola outbreak and biodefence efforts.

Dimerix has received a US$10 million upfront payment from Everest Medicines under a regional licensing deal for DMX-200 targeting FSGS in Greater China, South Korea and Southeast Asia. This deal marks Dimerix’s fifth commercial partnership for DMX-200, collectively worth up to A$1.9 billion in milestones and royalties.

Artrya Limited marked its first full year of US commercial operations with a $25.18 million loss, driven by regulatory clearances, customer contracts, and an $80 million capital raise.

ReNerve Ltd (ASX:RNV) reported an 80% year-on-year revenue increase in Q4 FY26, backed by expanding product lines and a $5 million funding facility. The company is advancing FDA approvals and growing its global distribution footprint, targeting a rapidly expanding $6.19 billion nerve repair biomaterials market.

Atomo Diagnostics has appointed Dr Cheri Walker as interim CEO, replacing founder John Kelly who steps down after 15 years. The leadership change aligns with the company's shift towards commercial growth in the US and Europe.

ImpediMed has secured FDA 510(k) clearance for its SOZO Digital Health Platform to assess sarcopenia risk, marking it as the only FDA-cleared bioimpedance spectroscopy solution for this clinical application. This clearance enables clinicians to non-invasively monitor muscle loss in cancer and chronic disease patients, potentially improving treatment outcomes.

Entropy Neurodynamics has partnered with BioCina to establish GMP manufacturing for its intravenous psilocin formulation TRP-8803, a critical step toward late-stage clinical trials and commercialisation.

Pro Medicus delivered a robust FY26 with 28% underlying revenue growth, a surge in new contract wins worth $407 million, and a 25% increase in fully franked dividends, underpinned by strong AI product development and rapid implementations.