Latest Fda News

Tissue Repair Limited reports steady progress in its Phase 3 clinical trials for chronic wound treatment and advances regulatory filings for its TR Pro+® product, while gearing up for a major commercial rollout in early 2026.

Atomo Diagnostics reported strong commercial momentum in Q1 FY26, highlighted by a key FDA submission for its FebriDx test and a successful capital raise of $1.3 million. The company also showcased promising clinical data for its Active Syphilis test and expanded its HIV Self-Test distribution channels.

Neurizon Therapeutics has secured FDA clearance to resume clinical trials for its lead ALS drug NUZ-001, alongside a $5.2 million capital raise and a key licensing deal with Elanco Animal Health. These developments position the company for a critical growth phase in neurodegenerative disease therapeutics.

BlinkLab has completed its U.S. autism pilot study with strong diagnostic accuracy and expanded its pivotal FDA trial to seven leading research centers, positioning itself for regulatory submission in late 2026.

LTR Pharma has made significant strides towards its US market debut with ROXUS, bolstered by expert appointments and peer-reviewed clinical data validating its rapid-onset ED treatments.

Dimerix Limited reports solid progress in its Phase 3 trial for DMX-200 targeting rare kidney disease FSGS, backed by orphan drug status in Japan and a robust cash position. The company prepares to engage the FDA on new data supporting regulatory approval.

Immutep Limited reports strong progress in its Phase III lung cancer trial with over 170 patients enrolled, alongside positive FDA feedback and a robust cash position supporting ongoing development.

Radiopharm Theranostics has secured FDA approval to initiate a Phase I trial targeting B7H3 and raised A$40 million to accelerate its radiopharmaceutical programs. The company also appointed renowned oncologist Dr Oliver Sartor to its Scientific Advisory Board.

Anteris Technologies Global Corp. has raised A$38.5 million in a private placement to accelerate the global commercialization and pivotal clinical trial of its innovative DurAVR® transcatheter aortic valve replacement device.

Neurotech International has initiated an Authorised Prescriber program for its lead therapy NTI164, expanding access for children with neurodevelopmental disorders in Australia. The company also secured a Rare Pediatric Disease Designation from the US FDA for NTI164 in Rett Syndrome, marking a key regulatory milestone.

dorsaVi reports breakthrough RRAM sensor performance and secures a major US physical therapy deal, backed by a $5 million capital raise and new leadership appointments.

Anteris Technologies has enrolled the first patients in its pivotal PARADIGM Trial, testing the DurAVR Transcatheter Heart Valve against leading competitors in a global study.