Latest Fda Approval News

The Treasurer has expressed preliminary concerns that Cosette Pharmaceuticals’ proposed acquisition of Mayne Pharma could harm Australia’s economy, citing plans to close a key Adelaide manufacturing site. Mayne Pharma disputes these claims and urges a resolution before the scheme deadline.

Bubs Australia reported a 30% increase in net revenue to $25.6 million for Q1 FY26, driven by robust US sales and a return to profitability with positive EBITDA. Despite inventory challenges in other regions, the company maintains a solid cash position and anticipates FDA approval by year-end.

PainChek has secured FDA De Novo clearance for its Adult App, opening immediate access to a $175 million AUD US long-term care market and advancing its Infant App commercialization targeting a $15 billion AUD global opportunity.

Mach7 Technologies reports a pivotal first quarter for FY26, marked by the initial go-live of a major U.S. Veterans Health Administration contract, leadership changes, and a strategic business reset.

Echo IQ Limited has advanced its EchoSolv heart failure solution towards FDA submission, driven by a landmark clinical validation study and a sharp rise in US platform adoption. Strategic partnerships and international expansion efforts underscore the company’s growing footprint in cardiology AI.

Cleo Diagnostics has successfully completed Stage 1 of the Medical Device Single Audit Program, marking a significant step toward FDA submission and global commercialisation of its ovarian cancer test.

Island Pharmaceuticals has completed its acquisition of the broad-spectrum antiviral Galidesivir and is progressing regulatory discussions with the FDA to fast-track approval using the Animal Rule, backed by compelling preclinical data.

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.

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.

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.

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.

Optiscan Imaging Ltd secured $17.75 million in a fully underwritten equity raise, fueling clinical studies and regulatory preparations for its innovative medical imaging devices. The company also reported progress in international trials and strengthened its cash position to nearly $20 million.