Latest Fda Submission News

Island Pharmaceuticals has raised $350,000 through an options exercise by substantial shareholder MWP Partners, reinforcing confidence in its antiviral drug development pipeline.

Optiscan Imaging Ltd has launched its first in-human breast cancer study and unveiled a new veterinary imaging device, while securing a key US collaboration to support FDA submissions.

Island Pharmaceuticals has completed its acquisition of the broad-spectrum antiviral Galidesivir ahead of schedule, setting sights on expedited FDA approval leveraging the Animal Rule.

Neurizon Therapeutics has made significant strides in developing its lead ALS drug candidate NUZ-001, unveiling a new liquid formulation and submitting a key regulatory response to the FDA. Clinical and preclinical data bolster hopes for broader neurodegenerative applications.

SomnoMed reports a robust Q4 FY25 with 25% revenue growth and a milestone of treating over 1 million patients, while gearing up for significant capacity expansion and clinical advancements.

Bubs Australia Limited reports a strong FY25 with 29% revenue growth to $102.5 million, positive EBITDA turnaround, and sustained cash flow improvements. The company also advances its US market ambitions with a key FDA submission underway.

Artrya has launched its AI-powered Salix Coronary Anatomy platform in the U.S. and submitted its Coronary Plaque module for FDA clearance, marking a key step in its commercial expansion. A new five-year contract with Tanner Health signals the start of U.S. revenues.

Echo IQ has secured a strategic collaboration with the Mayo Clinic Platform and raised $17.3 million, advancing its AI-driven cardiology tools towards FDA clearance and US commercial scale.

Cleo Diagnostics reports steady progress in its ovarian cancer diagnostic test development, with clinical trial recruitment on track and strategic access to major biobanks enhancing its regulatory pathway.

PainChek has completed its final FDA submission for the PainChek Adult App, targeting the US long-term care market with a potential $100 million annual opportunity. A regulatory decision is expected within 75 days, setting the stage for rapid commercialisation.

Lumos Diagnostics has inked a landmark six-year exclusive distribution agreement with PHASE Scientific for its FebriDx® rapid diagnostic test in the US, potentially unlocking nearly half a billion Australian dollars in revenue contingent on FDA approval.

Imricor Medical Systems has secured key European regulatory approvals for its second-generation NorthStar system and initiated its commercial launch, while US FDA submissions progress amid some delays.