Latest Fda News

Mayne Pharma has voluntarily withdrawn a speaker presentation for its contraceptive NEXTSTELLIS® following an FDA Untitled Letter concerning promotional claims.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.

Lumos Diagnostics has secured its largest single US purchase order for its rapid respiratory test FebriDx, signaling growing adoption in American healthcare settings.

Anteris Technologies has submitted its FDA Investigational Device Exemption for the pivotal PARADIGM Trial of its DurAVR heart valve and marked a milestone of 100 patients treated, while expanding manufacturing capacity amid rising R&D costs.

Neuren Pharmaceuticals has received official FDA minutes confirming the primary endpoints for its pivotal Phase 3 trial of NNZ-2591 targeting Phelan-McDermid syndrome, reinforcing the positive signals from earlier studies.

Cleo Diagnostics has completed alpha testing of its ovarian cancer pre-surgical triage assay kits, confirming robust performance and differentiation between benign and malignant disease. The company now moves forward to assay optimisation and manufacturing scale-up, edging closer to FDA submission and commercial launch.

Universal Biosensors reports a 6% sales increase in Q1 2025, driven by strong growth in wine and veterinary biosensors, while preparing to launch its innovative water testing product later this year.

Orthocell has rapidly expanded its US distributor network for Remplir™, surpassing its target ahead of schedule and positioning itself for imminent sales in the $1.6 billion nerve repair market.

Acrux Limited, partnering with TruPharma, has introduced its Dapsone 7.5% Gel in the US, featuring a unique tube packaging that aims to improve patient convenience and reduce environmental impact.

AVITA Medical reveals a bold expansion plan targeting a $3.5 billion U.S. acute wound care market by 2025, driven by a multi-product portfolio and sustained revenue growth.

Alterity Therapeutics is set to present compelling Phase 2 clinical trial results for ATH434 at the 2025 International Multiple System Atrophy Congress, highlighting slowed disease progression and biomarker engagement in MSA patients.