Latest Fda News

Echo IQ’s application for a key US procedural code was rejected but the company plans a swift resubmission, maintaining confidence in its US commercial rollout.

Island Pharmaceuticals has raised $3.6 million through a strategic share placement to advance its lead antiviral drug ISLA-101’s clinical development and broaden its asset portfolio ahead of pivotal Phase 2a/b trial results.

EMVision Medical Devices has enhanced its AI-powered stroke diagnostic algorithm, achieving a notable 95% sensitivity and 80% specificity in recent tests. This progress sets the stage for upcoming pivotal trials and regulatory milestones.

Clarity Pharmaceuticals has initiated its second registrational Phase III AMPLIFY trial for the Cu-SAR-bisPSMA PET imaging agent targeting biochemical recurrence of prostate cancer. The multi-centre study aims to generate critical data supporting FDA approval and could redefine prostate cancer diagnostics.

ITM Isotope Technologies Munich SE and Radiopharm Theranostics have entered a strategic supply agreement for the critical radioisotope Lutetium-177, underpinning Radiopharm’s clinical development of targeted cancer therapies.

Cynata Therapeutics confirms that the recent FDA orphan-drug exclusivity granted to Ryoncil® will not block approval of its CYP-001 therapy, highlighting key differences in drug composition and patient indications.

Recce Pharmaceuticals has successfully raised A$8.4 million through an entitlement offer and placement to fund pivotal Phase 3 clinical trials, advancing its synthetic anti-infective pipeline towards commercialisation in 2026.

Mesoblast has been granted a seven-year orphan-drug exclusivity by the FDA for its cell therapy Ryoncil, reinforcing its market position in treating steroid-refractory acute graft versus host disease in children.

Paradigm Biopharmaceuticals has secured centralised US ethics approval for its pivotal Phase 3 trial of injectable pentosan polysulfate sodium (iPPS) targeting moderate to severe knee osteoarthritis, setting the stage for patient enrolment in Q3 2025.

Mayne Pharma has voluntarily withdrawn a speaker presentation for its contraceptive NEXTSTELLIS® following an FDA Untitled Letter concerning promotional claims. The company confirms this does not impact sales or its planned merger with Cosette.

Mayne Pharma has addressed a sharp share price decline following the public release of an FDA Untitled Letter, confirming no undisclosed material information and reaffirming compliance with ASX rules.

EBR Systems has won FDA approval for its pioneering leadless WiSE CRT System, setting the stage for a phased US commercial rollout. The company also secured key Medicare reimbursement pathways and expanded manufacturing capacity, though financial sustainability remains a concern.