Latest Fda News

Nyrada Inc. reported a $3.19 million loss for the half-year ending December 2025, while advancing its lead drug candidate Xolatryp® into Phase IIa clinical trials targeting heart attack treatment.

Orthocell has secured a $3 million R&D tax refund, lifting its cash reserves to nearly $50 million and reinforcing its financial strength as it pushes commercialisation of its nerve repair product Remplir™ across key global markets.

Adherium Limited has raised $6.7 million through a Placement and Institutional Entitlement Offer, positioning itself to expand its digital respiratory management solutions and advance value-based care contracts with US insurers.

Cleo Diagnostics has chosen Bio-Techne’s next-generation Ella™ platform to enhance its ovarian cancer blood test, aiming for faster, more precise results and a streamlined path to FDA approval.

Telix Pharmaceuticals has lodged a European marketing authorization application for TLX101-Px, a novel PET imaging agent targeting glioma brain cancer, aiming to enhance diagnostic precision and patient access across major European markets.

Nexalis Therapeutics has completed a key capital raising milestone, issuing new shares, options, and performance rights following shareholder approval. This move supports the company’s clinical-stage drug development programs targeting pain and mental health.

Botanix Pharmaceuticals has secured approximately A$45 million through a two-tranche placement and an underwritten security purchase plan to fund API purchases, derisk its supply chain, and accelerate growth of its flagship product Sofdra.

Adherium Limited launches a A$7.52 million equity raising to fund commercial expansion of its Hailie SmartInhaler remote patient monitoring platform targeting asthma and COPD patients in the US. The company aims to scale patient numbers and progress towards value-based care contracts with major insurers.

Clarity Pharmaceuticals’ Cu-64 SAR-bisPSMA diagnostic agent significantly outperformed the current standard Ga-68 PSMA-11 in detecting prostate cancer recurrence, more than doubling lesion and patient detection rates in a pivotal head-to-head trial.

AVITA Medical reported an 11% increase in sales revenue for 2025, driven by deeper market penetration and new product launches, while reducing its net loss by 21%. The company secured a $60 million senior secured credit facility but flagged substantial doubt about its ability to continue as a going concern.

BlinkLab has expanded its pivotal FDA 510(k) autism diagnostic trial to nine top U.S. sites, adding Drexel University ahead of the Q1 2026 study start. This move follows a successful pilot study that exceeded FDA benchmarks, positioning BlinkLab Dx 1 for regulatory clearance.

Island Pharmaceuticals has confirmed the material significance of recent FDA feedback on its Galidesivir development pathway and addressed ASX queries on disclosure timing and capital raising activities.