Latest Fda Approval News

Alterity Therapeutics has bolstered its Phase 2 data for ATH434 in Multiple System Atrophy and is advancing regulatory plans for a pivotal Phase 3 trial, supported by a robust cash position of A$49.2 million.

PainChek has secured FDA De Novo clearance, enabling entry into the vast US healthcare market with a $3 billion Remote Therapeutic Monitoring opportunity. The company reports $5.6 million contracted ARR and a strong global footprint in aged care.

Mesoblast Limited reported a 60% jump in Ryoncil sales to US$35 million for the December quarter, alongside securing a US$125 million credit facility that enhances its financial flexibility and supports ongoing clinical development.

Imagion Biosystems has completed manufacturing its MagSense® HER2 imaging agent and is preparing for a key FDA submission, while appointing a new president to lead its US operations.

Dimerix Limited has completed recruitment for its pivotal ACTION3 Phase 3 trial targeting a rare kidney disease, secured positive FDA feedback on trial endpoints, and reported a solid cash position of AU$38.5 million at the end of 2025.

Acrux Limited reports solid revenue growth and increased cash reserves in the December quarter, driven by expanding its topical generics portfolio in the US and strategic moves into female Hormone Replacement Therapy.

PainChek has secured FDA-regulated medical device status, enabling US Remote Therapeutic Monitoring reimbursement and opening a major US growth avenue. The company targets musculoskeletal pain management in non-verbal dementia patients, a largely underserved market.

Imricor Medical Systems has achieved a major milestone with FDA clearance for its NorthStar Mapping System, the first MRI-native 3D cardiac mapping platform approved in the US. This approval positions Imricor at the forefront of MRI-guided cardiac procedures in the world’s largest electrophysiology market.

Cleo Diagnostics has broadened its U.S. market opportunity to around 2 million women annually and is on track to complete its pivotal clinical trial early this year, supported by a $5 million capital raise and regulatory progress.

Patrys Limited has acquired Reliis, gaining a promising injectable formulation of quetiapine aimed at treating delirium with a rapid FDA approval pathway. This move positions Patrys at the forefront of addressing a significant unmet medical need in critical care.

Imricor Medical Systems has achieved multiple world-first procedures using real-time MRI guidance for cardiac ablation, advancing clinical trials and regulatory progress amid a strategic commercial expansion.

Epiminder Limited has successfully listed on the ASX, raising $125 million to commercialise its FDA-approved Minder device. The company has initiated the first US implant and secured five leading medical centres for its DETECT study.