Latest Fda Approval News

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.

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.

Argenica Therapeutics has completed patient dosing in its Phase 2 trial of ARG-007 for acute ischaemic stroke, with topline data expected in Q3 2025. The company also plans to submit its Investigational New Drug application and Fast Track request to the FDA imminently.

Universal Biosensors reported a 28% increase in customer receipts to $1.6 million for Q1 2025, alongside improved cash flow and plans for a new product launch later this year.

LTR Pharma reports strong Q1 2025 progress with FDA pre-IND meeting success, scientific acclaim for SPONTAN’s rapid absorption, and strategic launch of ROXUS to fast-track US market entry.

Nyrada Inc. posted a significant $2.46 million loss for H1 FY25, driven by increased R&D spend, while advancing its lead drug NYR-BI03 into first-in-human trials following regulatory approval.