Latest Fda Approval News

UC San Diego Health has begun clinical use of 4DMedical’s CT – VQ™, marking the fourth leading US academic medical centre to adopt this innovative lung imaging technology since FDA clearance. This milestone underscores 4DMedical’s rapid commercial traction and growing influence in respiratory diagnostics.

Island Pharmaceuticals has been granted a key US patent for Galidesivir, extending intellectual property protection through 2031 for treating filoviridae viruses including Marburg and Ebola. This milestone aligns with the company’s clinical development strategy and recent FDA regulatory progress.

BlinkLab Limited has secured independent scientific validation for its smartphone-based autism diagnostic technology through publication in the prestigious journal Autism Research, marking a significant milestone ahead of its FDA regulatory trial.

Mesoblast has refinanced its senior debt with a new US$125 million, five-year credit facility that lowers borrowing costs and preserves key assets, positioning the company for strategic growth.

InhaleRx Limited has successfully closed its entitlement offer and placement, raising $857,730 to support the clinical development of inhaled treatments targeting cancer pain and mental health conditions.

Neurizon Therapeutics has launched a A$24.2 million equity raise to fund the next phase of clinical trials for its lead drug NUZ-001 targeting ALS, supported by a global licensing deal and a flexible convertible note facility.

Saluda Medical has received CE certification for its EVA™ Sensing Technology, enabling commercialisation in Europe and recognition in Australia following prior FDA approval. This milestone sets the stage for a broader rollout of its personalised spinal cord stimulation therapy in early 2026.

Clarity Pharmaceuticals has secured positive FDA guidance to initiate a pivotal Phase III trial of its Cu-64 SARTATE diagnostic agent for neuroendocrine tumours, aiming to improve detection and patient outcomes.

Cleo Diagnostics has raised $5 million to support the U.S. commercial launch of its Pre-Surgical Ovarian Cancer Test and accelerate development of a mass screening test, signaling strong investor confidence in its technology.

BlinkLab Limited has appointed its Co-Founder and CEO, Dr Henk-Jan Boele, as Managing Director to steer the company through its pivotal FDA 510(k) trial for its autism diagnostic technology. The move coincides with key board changes and signals a strategic shift as BlinkLab prepares for early commercialisation.

Island Pharmaceuticals has inked a Master Service Agreement with Texas Biomedical Research Institute, enhancing its strategic position to advance Galidesivir through the FDA Animal Rule pathway. This partnership aligns with US government priorities on viral threats and sets the stage for a planned clinical program in early 2026.

Neuren Pharmaceuticals’ partner Acadia secures FDA approval for DAYBUE STIX, a new powder formulation of trofinetide offering greater flexibility for Rett syndrome patients. This milestone expands treatment options and sets the stage for increased royalty revenue in 2026.