Latest Fda News

PYC Therapeutics strengthened its financial footing with a $600 million capital raise and made notable clinical progress across four RNA therapeutic programs targeting genetic diseases.

Cambium Bio has secured FDA agreement on a streamlined single pivotal Phase 3 trial for Elate Ocular®, cutting development costs and timelines. Despite a AUD 4.1 million loss for FY2026, the company strengthened its funding position and manufacturing partnerships ahead of patient dosing targeted for late 2026.

OncoSil Medical lifted revenues 44% in FY26 to $1.68 million and trimmed losses by 28% to $10.86 million, buoyed by key regulatory approvals including FDA HDE and Australian TGA listings. The company is poised for commercial launches in the US and Australia, with strong clinical data underpinning its growth.

Alterity Therapeutics posted a 285% jump in revenue to A$1.72 million but also a 93% rise in net loss to A$23.4 million for FY2026. The company secured FDA alignment on a single pivotal Phase 3 trial for ATH434 in Multiple System Atrophy, setting the stage for trial start by year-end.

4DMedical’s CT:VQ™ lung imaging technology secured FDA clearance and CMS reimbursement, driving rapid adoption in top US medical centres and expanding its addressable market to $3 billion with new clinical programs and European contracts.

Memphasys has secured early Thai FDA approval for its Felix™ System, triggering a three-year exclusive distribution deal with IVF Envimed and prompting additional orders amid strong clinic interest.

Immuron Limited posted a 6% rise in FY26 sales to $7.7 million, improved its net loss by $1.4 million, and secured FDA approval for IMM-529, underpinning a strategic pivot towards profitability and geographic expansion.

Saluda Medical delivered FY26 revenue of US$90.2 million, beating guidance with strong US and international growth, while reporting a flat net loss of US$149.6 million amid ongoing heavy investment. The company’s FDA approval of its CAP24 paddle lead opens a new US surgical market segment.

Imricor Medical Systems and Philips have launched a combined interventional MR lab solution integrating Philips’ 1.5T BlueSeal MRI with Imricor’s MR-compatible systems, targeting cardiac electrophysiology and setting a new standard for MR-guided interventions.

Percheron Therapeutics has partnered with Vanderbilt Health to initiate a clinical trial testing HMBD-002 in combination with standard treatments for high-risk acute myeloid leukaemia and myelodysplastic syndrome, targeting a recruitment start in late 2026.

LTR Pharma is shifting gears from clinical trials to commercial rollout, securing US partnerships for ROXUS and reporting encouraging SPONTAN Phase II data that supports FDA approval ambitions.

Actinogen Medical reported a $15.38 million loss for FY2026 while progressing its lead Alzheimer's drug Xanamem toward pivotal trial results expected this November. The company secured regulatory alignment and strengthened its cash position to fund operations through mid-2027.