Latest Fda Approval News

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.

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.

The week was split between big earnings reactions and small-cap rocks-and-rigs rallies. Pro Medicus sank despite record numbers, while a handful of explorers jumped on fresh discoveries and policy wins.

Healthcare stocks split into two stories this week: big names sold off hard, while a few small caps ran on clear news. The biggest moves came from a sharp fall in Pro Medicus and Cochlear, while Noxopharm jumped after a top-tier journal publication.

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.

Neuren Pharmaceuticals has initiated a discretionary on-market share buy-back program of up to 5%, citing a strong cash position and undervaluation relative to internal and analyst assessments.

A single exploration name blew the doors off the leaderboard, while two well-known uranium plays and a Nevada explorer sank hard. Behind the noise: deals got closer to completion, big raisings reset prices, and several “good news” gaps didn’t survive the week.

A single diagnostics update sparked a breakout week, while a handful of biotech names sold off hard despite busy newsflow. Capital raisings, takeover steps and US market pushes kept healthcare in motion heading into mid-February milestones.

Neuren Pharmaceuticals has dosed the first patient in its groundbreaking Phase 3 trial of NNZ-2591 for Phelan-McDermid syndrome, a rare genetic disorder with no approved therapies. The trial marks a significant step forward for the PMS community and rare disease drug development.