Latest Fda Approval News

Echo IQ Limited has secured FDA clearance for its EchoSolv AS technology and appointed a US-based CEO, marking a pivotal shift towards commercialisation in the American healthcare market.

NeuroScientific Biopharmaceuticals has initiated critical IND-enabling studies for its glaucoma drug candidate EmtinB, backed by a solid cash position of A$4.5 million as of December 2024. Preliminary melanin binding results are shaping the path toward first-in-human trials.

Algorae Pharmaceuticals reports robust progress in its drug development pipeline, highlighted by promising preclinical results for cardiovascular and dementia candidates and significant AI platform enhancements.

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.