Latest Fda News

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.

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.

Island Pharmaceuticals has enrolled all subjects in the Phase 2b arm of its ISLA-101 dengue fever clinical trial, advancing its antiviral drug development with key results expected in 2025.

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.

Recce Pharmaceuticals has successfully dosed all patients in its Phase II trial of RECCE® 327 topical gel for acute bacterial skin infections, showing encouraging preliminary efficacy and safety data. The company is preparing for pivotal Phase III trials in Australia and Indonesia, targeting a significant global market opportunity.

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.

Visioneering Technologies reports promising interim results from its PROTECT trial, showing significant control of myopia progression in children using NaturalVue® Multifocal lenses.