Latest Fda Approval News

Imricor Medical Systems has submitted the third of four Premarket Approval modules to the FDA, marking a key step towards US approval of its MR-guided cardiac ablation devices.

Argenica has completed the last FDA-mandated cardiac safety assay for its stroke drug ARG-007, paving the way to lift the clinical hold and initiate Phase 2b trials in the US.

Island Pharmaceuticals has expanded its partnership with USAMRIID to conduct a pivotal Galidesivir dose optimisation study against Marburg virus, targeting topline results in the second half of 2026.

OncoSil Medical has cleared a major regulatory hurdle as its Humanitarian Device Exemption application nears FDA approval, while its TRIPP-FFX trial shows promising results combining OncoSil with standard chemotherapy for pancreatic cancer.

EBR Systems has secured a significant regulatory milestone as the US Centers for Medicare & Medicaid Services (CMS) initiates a National Coverage Determination (NCD) for its WiSE wireless cardiac pacing system, aiming for approval by early 2027.

PolyNovo has completed its pivotal US clinical trial report for NovoSorb BTM and adjusted its FDA Premarket Approval submission timeline to late 2026 to incorporate updated regulatory requirements and additional data.

Bubs Australia expects FY26 revenue between $105 million and $115 million, with underlying EBITDA forecast at $4 million to $8 million despite external challenges including regulatory delays and increased air freight costs.

Immuron Limited has responded to an ASX price query following a sharp rise in its share price and trading volume, confirming no undisclosed information but pointing to a recent CEO presentation as a possible driver.

Osteopore has secured Hainan FDA approval to clinically use and sell its custom orthopaedic devices at Shanghai Ruijin Hospital’s Hainan branch, marking a key step towards wider China market access. The company has scheduled its first patient surgery for June 2026.

Vitrafy Life Sciences has achieved a major validation milestone with US Army-backed Phase II results showing its no-wash platelet cryopreservation protocol delivers 94% post-thaw recovery, outperforming existing standards and advancing FDA registration plans.

AFT Pharmaceuticals posted a 22% revenue jump to NZ$254.7 million and a 39% increase in operating profit to a record NZ$24.4 million for FY26, exceeding guidance. The company targets over NZ$300 million revenue for FY27, fueled by international expansion and a deepening R&D pipeline.

Invion Limited has partnered with South Korea's SANGMYUNG Innovation to explore its Photosoft™ photodynamic therapy for wet age-related macular degeneration, addressing a large unmet medical need in ophthalmology.