Latest Fda News

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.

Optiscan Imaging has fast-tracked Stage 2 of its pioneering head and neck cancer imaging study, moving into live intraoperative imaging ahead of schedule. This advancement supports FDA regulatory efforts and enhances the company’s AI imaging development.

Telix Pharmaceuticals reported a 21% year-on-year revenue jump to US$247 million in Q2 2026, buoyed by strong Precision Medicine sales and a new Regeneron partnership. The company also secured FDA alignment on a pivotal prostate cancer trial and expanded its manufacturing footprint.

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.

PainChek appoints seasoned US medtech executive Karen Holzberger as CEO to spearhead growth following FDA clearance and major US contracts.

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.

Memphasys delivered a record $150,000 quarterly revenue, secured its largest Felix™ supply contract with Monash IVF, and expanded into UK and Southeast Asian IVF markets, positioning for accelerated growth in FY27.

Neurotech International has locked in a $3.15 million secured loan against its anticipated R&D tax incentives to fund pivotal Phase III autism trials and ongoing operations.

EMVision Medical Devices has hit key enrolment milestones in its pivotal brain scanner trial, expanded clinical endpoints, and maintained a strong cash position with $17.1 million on hand.

Starpharma launches a fully underwritten $32 million entitlement offer to fund the Phase 1 trial of its DEP® HER2-Lutetium radiopharmaceutical and accelerate its targeted oncology asset development.