Latest Fda Approval News

Universal Biosensors is expanding its handheld testing portfolio with the upcoming AQUASCOUT water sensor and growing sales of its FDA-approved Xprecia Prime blood coagulation device, targeting multi-billion-dollar markets.

Clarity Pharmaceuticals will present compelling data on its 64Cu-SAR-bisPSMA diagnostic agent at two leading oncology conferences, highlighting earlier and more accurate prostate cancer lesion detection than current standards.

EBR Systems has signed a long-term lease for a 51,000 sq ft facility in Santa Clara, California, positioning itself for significant manufacturing expansion and future growth in wireless cardiac pacing technology.

Telix Pharmaceuticals has finalized its acquisition of RLS (USA) Inc., significantly expanding its radiopharmaceutical footprint across the United States with a network of over 30 radiopharmacies.

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.

Clarity Pharmaceuticals has secured a second FDA Fast Track Designation for its 64Cu-SAR-bisPSMA diagnostic agent, aiming to revolutionize prostate cancer imaging and speed regulatory approval.

InhaleRx has locked in a $38.5 million funding deal with Clendon Biotech Capital, enabling expanded Phase 2 trials for its inhaled breakthrough cancer pain and panic disorder treatments. The company also filed a key international patent, positioning itself for a faster path to FDA approval.

Nyrada Inc. reports promising preclinical results for its lead drug NYR-BI03, showing an 86% cardioprotective effect, alongside a strong financial position bolstered by a AU$3.29 million capital raise. The company has submitted its Phase Ia clinical trial package, setting the stage for human testing.

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.

Bubs Australia has reported a strong Q2 FY25 performance with a positive EBITDA turnaround and robust revenue growth, while advancing its critical FDA clinical trial in the US.

Respiri Limited has completed its acquisition of Orb Health Inc. for US$9 million in shares, marking a strategic move to strengthen its foothold in the US connected and chronic care market. The integration promises operational cost savings and expanded service offerings.

PolyNovo Limited reports a robust 22.8% revenue increase in 1H FY25, driven by strong U.S. and international sales growth and progressing FDA approval efforts for its NovoSorb platform.