Latest Fda Authorisation News

Bubs Australia has expanded its US footprint to more than 12,000 stores after securing permanent FDA authorisation, but quarterly revenue fell 9.8% and operating cash outflow increased. The company ended September with A$13.4 million of available liquidity, equivalent to 2.2 quarters at the reported cash-burn rate.

Bubs Australia delivered 9.2% revenue growth and a sharp underlying EBITDA improvement in FY26, but statutory losses, weaker margins and negative operating cash flow expose the cost of its expansion. Permanent US FDA authorisation removes a major regulatory hurdle, while the annual report still flags material uncertainty around ongoing funding and cash generation.

Bubs Australia has secured permanent US FDA authorisation for three infant formula products, removing a regulatory barrier in the company’s largest market. The approval supports possible portfolio expansion and contract manufacturing, but the presentation contains no new earnings guidance or quantified financial benefit.

Epiminder has ramped up enrolment in its DETECT study, contracting 18 US medical centres and maintaining a robust $83.8 million cash position to fund its Minder device commercialisation through 2028.