Latest Fda Approval News

Artrya Limited reported a 44% increase in its half-year loss to $10.7 million as it transitioned from development to commercial operations in the US, securing FDA clearance and signing three foundation customers. An $80 million capital raise underpins its ambitious US expansion and ongoing product development.

Cyclopharm Limited reported a 17% revenue increase to a record $32.3 million in 2025, powered by a 226% surge in US Technegas sales. The company is accelerating its US rollout with plans for up to 300 installations in 2026, while advancing clinical trials beyond pulmonary embolism.

Cleo Diagnostics reported a 53% drop in revenues and a slight increase in net loss to $1.98 million for H1 2025, while progressing its pivotal FDA clinical trial for an ovarian cancer blood test with strong regulatory and commercial milestones.

Immuron Limited reported a narrower half-year loss alongside record sales growth and FDA approval for its IMM-529 drug candidate, signalling promising clinical and commercial momentum.

Epiminder Limited has reported a $21.7 million loss for the half-year ending December 2025, alongside a successful $125 million IPO that fuels its commercialisation of the FDA-approved Minder epilepsy monitoring device.

Imricor Medical Systems saw a sharp 69.5% decline in revenue for 2025, driven by clinical trial impacts, yet narrowed its net loss to $25.3 million as it secured FDA clearance for key products post-year-end.

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

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.

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.

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.

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.