Latest Fda Approval News

AVITA Medical reported a strong first quarter with revenues up 67% to $18.5 million, driven by expanded commercial sales and new product introductions. Despite a narrower net loss, the company faces ongoing challenges from revenue covenants and macroeconomic pressures.

Echo IQ has raised $17.3 million through a strongly supported institutional placement to fund US commercialization and FDA approval efforts for its EchoSolv AI cardiology products.

Dimerix has received a US$30 million upfront payment from Amicus Therapeutics for exclusive US rights to DMX-200, a promising kidney disease therapy. The deal positions Dimerix for up to US$560 million in further milestones plus royalties, underpinning its global licensing strategy.

BlinkLab Limited has raised A$7.66 million through a well-supported placement to accelerate FDA regulatory trials for its autism and ADHD diagnostic platforms, leveraging its innovative smartphone-based technology.

Dimerix has inked an exclusive US licensing agreement with Amicus Therapeutics for DMX-200, a promising Phase 3 treatment for FSGS, unlocking $30 million upfront and up to $560 million in milestones.

Imagion Biosystems has progressed its MagSense HER2 breast cancer imaging agent towards a pivotal Investigational New Drug application with the FDA, backed by a solid funding runway exceeding 13 quarters.

TrivarX has launched a pivotal mental health clinical trial in partnership with the US Department of Veterans Affairs, leveraging its innovative ECG-based technology to screen for major depressive episodes. The company also secured $2.25 million in funding, positioning it for regulatory milestones ahead.

Mesoblast has commercially launched Ryoncil in the US for pediatric acute GVHD, backed by a strong cash position and advancing multiple cell therapy programs.

Adherium Limited reports a surge in US commercial patients for its Hailie Smartinhaler platform, alongside strategic hires and a new product launch compatible with AstraZeneca inhalers, underpinning plans for a capital raise.

INOVIQ Limited reports significant progress in its exosome-based cancer diagnostics and therapeutics, including expanded customer adoption, advanced AI screening tests, and strategic partnerships with leading research centres.

Optiscan Imaging Ltd has revealed its next-generation InForm™ pathology imaging device and strengthened its executive team, while reporting a robust cash position supported by a $1.775 million R&D tax refund for the quarter ended 31 March 2025.

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.