Latest Fda News

Botanix Pharmaceuticals reports robust early sales and expanding prescriber engagement for Sofdra™, its FDA-approved topical gel for excessive underarm sweating, signaling promising growth ahead.

Cochlear Limited has secured FDA approval for its latest Nucleus Nexa System and Kanso 3 sound processors, setting the stage for a US market debut in early FY26.

Nanosonics has launched trophon3, its next-generation ultrasound disinfection device, alongside a software upgrade for existing users, promising faster cycles and enhanced digital integration.

Prescient Therapeutics has opened a Share Purchase Plan to raise up to $7 million, offering shareholders discounted shares to fund the Phase 2 development of its targeted cancer therapy PTX-100.

EMVision Medical Devices has activated five of six pivotal trial sites for its emu™ bedside brain scanner, advancing towards FDA clearance while launching a parallel innovation study in Australia.

Echo IQ has initiated a pivotal clinical validation study with the Mayo Clinic Platform to test its EchoSolv HF software, marking the final step before its planned FDA submission in late 2025.

Mesoblast has secured FDA agreement on key requirements for its Biologics License Application for Revascor, targeting ischemic heart failure patients with reduced ejection fraction. The company aims for accelerated approval by year-end 2025.

Prescient Therapeutics has launched a $7 million Share Purchase Plan at a notable discount to fund the next phase of clinical trials for its promising PTX-100 cancer therapy. The capital raise aims to accelerate progress toward regulatory approval and patient access.

Artrya Limited announces a strategic leadership reshuffle with co-founder John Konstantopoulos stepping into the CEO role as the company prepares for its U.S. commercial launch of the Salix® AI-powered platform.

Orthocell Limited has posted a record quarterly revenue of A$2.73 million, driven by strong Australian sales of its nerve repair product Remplir™, with US market expansion poised to accelerate in FY26.

Optiscan Imaging Ltd has commenced a landmark clinical study at Royal Melbourne Hospital, testing its cutting-edge InVue® and InForm™ devices to improve breast cancer surgery precision. The study aims to generate critical data for US FDA approval and could redefine surgical oncology workflows.

Cambium Bio has secured ethics approvals in Australia and the US to initiate pivotal Phase 3 trials of Elate Ocular, targeting moderate to severe dry eye disease, with patient dosing expected in October 2025.