Latest Fda News

Tetratherix Limited reported a $4.6 million statutory loss for the first half of FY26, driven by increased R&D and manufacturing investments, while making significant progress in clinical trials and securing key global partnerships.

Singular Health Group reported a 55% rise in net loss to $2.97 million for H1 FY2026, driven by share-based payments and strategic hires, while making significant progress in US commercial deployments and securing FDA clearance for its cloud-based 3D medical imaging platform.

PYC Therapeutics reported a narrowed half-year loss of $22.8 million while progressing four RNA drug candidates through clinical stages. The company announced a major $653 million capital raising to extend its cash runway to 2030 and support ongoing development.

Lumos Diagnostics has hit a key enrollment milestone in its BARDA-funded paediatric study for FebriDx®, unlocking a US$720,000 payment and edging closer to FDA expansion.

Neurotech International has reported positive long-term safety results for its lead drug candidate NTI164, bolstering its path towards regulatory approval and chronic use in paediatric neurological disorders.

Clarity Pharmaceuticals reports another metastatic prostate cancer patient achieving undetectable disease markers in its Phase II SECuRE trial, reinforcing promising efficacy and safety of its Cu-SAR-bisPSMA radiopharmaceutical.

Mesoblast Limited is set to release its half-year financial results and operational update, spotlighting its FDA-approved cell therapy and expanding international partnerships.

PolyNovo Limited reported a robust 25.2% increase in half-year revenue to A$75 million, driven by strong U.S. sales and product growth, despite a near break-even net profit impacted by a manufacturing slowdown and a fire at its R&D lab.

Cambium Bio has secured FDA clearance to begin Phase 3 dosing for its lead ophthalmology product, Elate Ocular®, alongside key global partnerships and a $2.4 million capital injection from a major shareholder.

Telix Pharmaceuticals delivered a strong 56% revenue increase in 2025, driven by U.S. sales of Illuccix and the launch of Gozellix, while advancing its therapeutic pipeline and expanding global manufacturing capabilities. Despite a net loss, the company is investing heavily in R&D and sustainability initiatives aligned with climate-related disclosures.

AdAlta Limited reported a $2.44 million loss for H1 FY26 while progressing a key CAR-T therapy collaboration and raising $2.8 million in capital. The company’s ‘East to West’ immunotherapy strategy gains momentum with regulatory tailwinds and cost efficiencies.

Arovella Therapeutics reported a 22% increase in half-year losses to $1.88 million while securing FDA acceptance of its IND application for lead asset ALA-101, paving the way for first-in-human trials.