Latest Fda News

Zelira Therapeutics has locked in a $650,000 loan facility secured against its anticipated FY25 R&D tax rebate, aiming to accelerate its HOPE SPV clinical trial and strengthen working capital.

Island Pharmaceuticals reported promising Phase 2a/b trial results for its dengue drug ISLA-101 and secured a strategic acquisition of the broad-spectrum antiviral Galidesivir, bolstering its pipeline and balance sheet.

Amplia Therapeutics has launched a $27.5 million capital raising to advance its lead drug Narmafotinib, a promising FAK inhibitor showing superior efficacy in pancreatic cancer trials. The funds will support ongoing and new clinical studies, positioning the company for pivotal regulatory milestones.

NeuroScientific Biopharmaceuticals has completed its acquisition of StemSmart technology, reporting promising clinical results in Crohn’s disease and GVHD, alongside a $3.5 million capital raise to fuel next-stage development.

Tetratherix Limited has marked a pivotal quarter with a $25 million ASX listing, an exclusive licensing agreement with Bio Optix for ophthalmic devices, and progress on FDA regulatory submissions for its prostate spacer product.

Argenica Therapeutics has dosed the final patient in its Phase 2 trial for ARG-007 in acute ischaemic stroke, with topline results expected in Q3 2025. Meanwhile, the FDA has placed a clinical hold on its US trial application, introducing uncertainty for US development.

InhaleRx Limited has secured key ethics approvals and initiated manufacturing for its inhaled drug candidates targeting breakthrough cancer pain and panic disorder, supported by a $38.5 million funding facility to accelerate development.

dorsaVi reports transformative performance improvements from integrating RRAM technology into its biomedical sensor platforms, promising faster, more durable, and energy-efficient wearable devices.

Genetic Signatures has formed a strategic partnership with Tecan and Repado to develop a fully automated, scalable infectious disease testing platform integrating advanced automation, compliant software, and proprietary assays.

Cleo Diagnostics reports steady progress in its ovarian cancer diagnostic test development, with clinical trial recruitment on track and strategic access to major biobanks enhancing its regulatory pathway.

PainChek has completed its final FDA submission for the PainChek Adult App, targeting the US long-term care market with a potential $100 million annual opportunity. A regulatory decision is expected within 75 days, setting the stage for rapid commercialisation.

Lumos Diagnostics reported a 12% revenue increase for FY25 and inked a landmark US$317 million exclusive distribution deal for its FebriDx test, while advancing its FDA CLIA waiver application.