Latest Fda News

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.

Respiri Limited reports a standout December quarter marked by a 67% surge in patient program enrolments and robust revenue growth, bolstered by strategic acquisition synergies from Orb Health. The company is poised for further expansion in 2025 amid promising contract negotiations and evolving US healthcare reimbursement policies.

4DMedical has signed a landmark commercial agreement with Qscan Radiology Clinics, marking its first Australian contract to integrate both Pulmonary Function and Pulmonary Structure imaging products.

SomnoMed reports a robust 19.8% revenue increase in Q2 FY25 and updates its full-year guidance, reflecting strong demand and operational improvements amid ongoing production enhancements.