Latest Fda Approvals News

INOVIQ's December quarterly update reveals significant progress in its cancer diagnostic and therapeutic programs, including a highly accurate ovarian cancer screening test and promising breast cancer therapeutics, supported by growing EXO-NET customer adoption and a solid cash position.

Optiscan Imaging Ltd reported a productive December quarter, marked by key product developments, strategic partnerships, and a stronger cash position, setting the stage for growth in medical and veterinary imaging markets.

PainChek Ltd reports robust growth with 100,000 contracted licences globally and positive FDA clearance progress, alongside a promising launch of its Infant App targeting a vast new market.

TrivarX has solidified its regulatory strategy for the pivotal MEB-001 trial with the FDA and unveiled a new algorithm that expands its mental health screening reach beyond sleep clinics.

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.