Latest Fda News

BCAL Diagnostics has acquired a 10.2% stake in Genetic Signatures for $1.39 million, aiming to merge early cancer detection with infectious disease diagnostics and expand its international footprint.

Island Pharmaceuticals has strengthened its intellectual property portfolio with a Singapore patent covering ISLA-101 for flavivirus infections, including Dengue and Chikungunya, extending commercial exclusivity to 2034 in a key Asia-Pacific market.

Imricor Medical Systems expands its US market reach with FDA 510(k) clearances for pediatric use of its NorthStar system and Vision-MR Diagnostic Catheter, enabling radiation-free cardiac catheterisations for children.

Mesoblast has received a Biologics License Application filing number from the FDA for rexlemestrocel-L, targeting life-threatening bleeding in end-stage heart failure patients with LVADs, advancing its regulatory journey with orphan drug and RMAT designations.

Echo IQ has raised approximately A$110 million through a heavily supported institutional placement to fund its US commercial rollout and speed up development of its AI-driven cardiovascular diagnostics.

Recce Pharmaceuticals has received a significant A$3.7 million income tax refund from the Australian Taxation Office, strengthening its cash position to approximately A$33.1 million as it prepares for critical Phase 3 clinical milestones.

AdAlta has met a key US$1 million milestone payment under its China collaboration, gaining critical clinical data and securing proprietary materials for Australian manufacturing of its lead CAR-T therapy BZDS1901.

Memphasys has locked in a three-year exclusive distribution agreement for its Felix™ sperm separation system in Thailand, targeting a key IVF market with 110 clinics and 20,000–30,000 cycles annually. The deal adds approximately A$430,500 in contracted revenue, lifting South-East Asian minimum contracts to about A$1 million and contributing to FY2026 Felix™ sales now exceeding A$3 million.

Imugene Limited reports a complete response in the first patient treated with azer-cel combined with BTK inhibitors in its Phase 1b trial, highlighting potential for resistant follicular lymphoma.

Saluda Medical has obtained FDA approval for its CAP24 surgical paddle lead, a first-of-its-kind device designed for closed-loop spinal cord stimulation, poised to broaden its US market reach and engage new surgical specialties.

Clarity Pharmaceuticals will present compelling data at EANM 2026 demonstrating its 64Cu-SAR-bisPSMA imaging agent’s superior detection of prostate cancer recurrence and promising therapeutic results from 67Cu-SAR-bisPSMA in advanced disease.

4DMedical has cleared a major regulatory hurdle with the Therapeutic Goods Administration approving its CT:VQ™ lung imaging software, paving the way for commercial use across Australia and strengthening its global footprint.