Latest Us Fda News

BlinkLab has launched its pivotal FDA registrational study for its AI-driven autism diagnostic app, BlinkLab Dx 1, following positive FDA feedback and promising preliminary results.

Island Pharmaceuticals reports promising safety and anti-dengue activity in its Phase 2a trial of ISLA-101 and has commenced the Phase 2b therapeutic arm, backed by a fresh A$3.5 million capital raise.

Neurizon Therapeutics reports encouraging 8-month interim results for its ALS drug NUZ-001, secures Orphan Medicinal Product Designation in Europe, and raises $885,000 through a share placement, maintaining a robust $14 million cash position.

IDT Australia reports a near doubling of quarterly revenue to $5.3 million, driven by explosive growth in its Advanced Therapies segment, with first-half revenue expected to jump 82%.

InhaleRx has corrected its quarterly report and revealed a $38.5 million funding deal to fast-track clinical trials for its inhaled therapies targeting breakthrough cancer pain and panic disorder, aiming for FDA approval.

IDT Australia has finalized a $20 million asset-based loan facility with ScotPac, replacing its previous $4.7 million NAB facility, to support its expanding sales pipeline and recent contract wins.

Imricor Medical Systems reports strong Q4 CY24 progress with successful FDA review, CE Mark submissions, and an 840% jump in consumables revenue, positioning the company for expanded global market penetration.

Island Pharmaceuticals has enrolled all subjects in the Phase 2b arm of its ISLA-101 dengue fever clinical trial, advancing its antiviral drug development with key results expected in 2025.

Orthocell Limited has reported a third consecutive quarter of record revenue, driven by strong sales growth and strategic market expansions, including a key US FDA submission for its nerve repair product Remplir™.