Latest Fda Approvals News

Dimerix Limited (ASX: DXB) has inked its fifth regional licensing agreement with Everest Medicines, boosting potential milestone payments to A$1.9 billion and expanded its kidney disease pipeline through the acquisition of DMX-652. The Phase 3 ACTION3 trial for DMX-200 remains statistically robust, with funding secured to advance both clinical programs.

Cyclopharm’s Technegas® has been named the preferred ventilation agent in new US lung imaging guidelines, marking the first update in 14 years and potentially accelerating adoption across American hospitals.

Saluda Medical capped FY26 with a 28% revenue surge, beating guidance at US$90.2 million, while FDA approval for its CAP24 paddle lead opens a new US surgical market segment.

Vitrafy Life Sciences reported a breakthrough 94.4% post-thaw platelet recovery in US Army Phase II testing, secured major US blood network partnerships, and raised $32 million to accelerate US expansion and device manufacturing.

Patrys Limited is pushing forward with a proprietary injectable formulation of quetiapine targeting the lucrative delirium treatment market, leveraging a faster, lower-cost FDA 505(b)(2) regulatory pathway and strong patent protection.

Dimerix has strengthened its kidney disease pipeline with a US patent grant for DMX-652, extending protection until 2043 and setting the stage for a Phase 2 trial targeting acute kidney injury after cardiac surgery.

AFT Pharmaceuticals has received tentative US FDA approval for its Scomara cream to treat Facial Angiofibromas in Tuberous Sclerosis, but US commercialisation is postponed until 2029 due to orphan drug exclusivity. The approval bolsters regulatory prospects in other key markets where AFT anticipates competitive advantages.

AFT Pharmaceuticals secures tentative FDA approval for Scomara cream to treat rare facial tumours but faces a US launch delay due to orphan drug exclusivity. The approval bolsters prospects in other markets where AFT expects competitive advantages.

Imricor Medical Systems has submitted its final 510(k) devices to the FDA, marking a major step towards commercialising its MRI-guided cardiac catheterisation platform in the US.

OncoSil Medical has gained Saudi FDA approval for its OncoSil™ device, enabling full reimbursement and commercial access in Saudi Arabia, the Middle East's largest healthcare market.

Dimerix has acquired DMX-652, a Phase 2-ready oral drug candidate targeting acute kidney injury, expanding its renal disease portfolio. The acquisition includes patent rights, an FDA-approved trial protocol, and funding to initiate clinical development.

Immuron Limited reported a 6% increase in FY26 sales to AUD 7.7 million, driven by strong gains in Canada and the US despite mixed Australian performance. Marketing initiatives and retail expansion underpin growth.