Latest Fda News

4DMedical has submitted its CT:VQ lung imaging technology for FDA clearance, aiming to disrupt the $1 billion US nuclear lung scan market with a non-nuclear, lower-cost alternative. Clinical studies show CT:VQ matches or exceeds existing nuclear imaging in accuracy and patient experience.

Neuren Pharmaceuticals posted record 2024 financials driven by DAYBUE royalties and advanced NNZ-2591 into Phase 3 trials, while launching a $50 million share buy-back amid volatile market sentiment.

Prescient Therapeutics has reached a pivotal milestone by dosing the first patient in its Phase 2a clinical trial of PTX-100 for relapsed/refractory Cutaneous T-Cell Lymphoma (CTCL), aiming to evaluate safety and efficacy across multiple international sites.

PainChek Limited has secured a pivotal reseller and integration deal with Eldermark Software, positioning its AI-driven pain assessment app for a major US market rollout pending FDA approval.

Recce Pharmaceuticals has secured a significant patent acceptance in China for its RECCE® anti-infectives, broadening its intellectual property footprint in the world’s second-largest pharmaceutical market.

4DMedical has submitted its CT:VQ™ software to the FDA, aiming to revolutionize lung ventilation and perfusion imaging by replacing traditional nuclear scans with a non-contrast CT-based solution.

Immutep’s novel immunotherapy combination with radiotherapy and KEYTRUDA® has met its primary endpoint in a Phase II trial for resectable soft tissue sarcoma, showing promising early signs of improved patient outcomes.

Neuren Pharmaceuticals has approved a significant long-term equity incentive plan tied to critical clinical and regulatory milestones for its drug candidate NNZ-2591, reinforcing management’s commitment to shareholder value.

EBR Systems has announced a fully underwritten A$55.9 million capital raise alongside a Security Purchase Plan to fund the commercial rollout of its FDA-approved WiSE CRT System, targeting a US$3.6 billion market opportunity in cardiac resynchronization therapy.

EBR Systems has raised A$55.9 million through a fully underwritten placement to fund the commercial rollout of its FDA-approved wireless cardiac pacing system, with plans for a limited market release in H2 2025 and expanded distribution in 2026.

Mayne Pharma has clarified why it did not disclose an FDA Untitled Letter to the market despite sharing it with its scheme bidder, reaffirming compliance with ASX rules amid recent share price volatility.

Mayne Pharma has firmly rejected Cosette Pharmaceuticals’ assertion of a Material Adverse Change that could derail their acquisition scheme, insisting the deal process continues as planned.