Latest Fda News

Amplia Therapeutics reports strong progress in its pancreatic cancer drug development, completing the ACCENT trial recruitment ahead of schedule and initiating a new US trial, while managing a $6.57 million loss for FY25.

Clarity Pharmaceuticals has successfully imaged the first patient in its pivotal Phase III AMPLIFY trial for Cu-SAR-bisPSMA, a next-generation diagnostic agent targeting recurrent prostate cancer. This milestone sets the stage for potential FDA approval and broader clinical adoption.

Avecho Biotechnology has received $1.66 million from the Australian Government’s R&D Tax Incentive, reinforcing its commitment to a pivotal Phase III trial for its CBD-based insomnia treatment and accelerating its commercial ambitions.

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.