Latest Fda News

Opthea Limited has spotlighted Sozinibercept as a potential game-changer in wet age-related macular degeneration (AMD) therapy, presenting compelling clinical data and a clear path to U.S. market entry.

TrivarX has secured positive feedback from the FDA on its pivotal trial design for MEB-001, an AI-driven algorithm targeting major depressive episode screening via sleep study data. The company is advancing site collaborations to launch a large-scale US trial.

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.

IDT Australia reports a near doubling of quarterly revenue to $5.3 million, driven by explosive growth in its Advanced Therapies segment, with first-half revenue expected to jump 82%.

EMVision Medical Devices reports strong progress in clinical trials for its emu™ Bedside Scanner, backed by robust cash reserves and strategic non-dilutive funding. The company is poised to commence pivotal FDA validation trials, marking a key step toward commercialisation.

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.

Dimerix Limited has inked a lucrative licensing agreement with Fuso Pharmaceutical for its kidney disease drug DMX-200 in Japan, while completing recruitment for its pivotal Phase 3 ACTION3 trial.

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.

Zelira Therapeutics has received a fourth funding tranche, bringing total investment to US$3.25 million to support FDA clinical trials of its HOPE® 1 cannabinoid medicine targeting irritability in autism spectrum disorder and Phelan-McDermid Syndrome.

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.

IDT Australia has finalized a $20 million asset-based loan facility with ScotPac, replacing its previous $4.7 million NAB facility, to support its expanding sales pipeline and recent contract wins.

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.