Latest Fda Approval News

Optiscan Imaging has launched a 35-patient clinical trial in the US to test its InVue™ and InForm™ platforms in head and neck cancer surgery, aiming to bolster its FDA submissions later this year.

Island Pharmaceuticals has obtained regulatory rights to reference critical Marburg-Angola virus natural history data, clearing a significant FDA hurdle for its antiviral Galidesivir. This milestone accelerates the path toward pivotal animal studies and potential FDA approval under the Animal Rule.

EMVision has accelerated recruitment in its pivotal emu™ brain scanner trial, surpassing 200 patients and advancing FDA discussions to broaden clinical endpoints, setting the stage for regulatory submission in early 2027.

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.

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.

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.

Clarity Pharmaceuticals reported a 67% increase in net loss to $107.2 million for FY26, driven by higher R&D spending, while advancing multiple Phase III trials and expanding manufacturing capacity ahead of commercialisation.

Argent BioPharma has secured a key FDA regulatory milestone with the establishment of an Investigational New Animal Drug (INAD) file for its CannEpil veterinary program, targeting cancer-related pain in companion animals.

Epiminder Limited reported a $42.7 million loss for FY26, driven by clinical trial and product development costs following a $125 million IPO. The company progresses its FDA-approved Minder implantable EEG monitor with a pivotal US trial and next-gen device on track for 2028 launch.

Control Bionics has secured MHRA registration for its NeuroStrip device, unlocking commercial supply in Great Britain and launching early trials with leading UK institutions.