Latest Fda Submission News

Vectus Biosystems has appointed Cardinal Health Regulatory Services as its US regulatory agent to manage FDA submissions for its lead fibrosis drug VB0004, marking a pivotal step towards clinical development in the US.

Cleo Diagnostics (ASX:COV) has entered the analytical validation phase for its ovarian cancer test, progressing toward an FDA 510(k) submission expected in early 2027.

Optiscan Imaging has begun commercial sales of its InSpecta™ microscopic imaging device in the US veterinary sector following FDA clearance, marking its first clinical device launch and a strategic expansion into a $15.87 billion market.

Echo IQ has raised approximately A$110 million through a heavily supported institutional placement to fund its US commercial rollout and speed up development of its AI-driven cardiovascular diagnostics.

Island Pharmaceuticals has kicked off GMP manufacturing of its antiviral Galidesivir to support late-stage Marburg virus studies under the FDA Animal Rule, marking a key step towards regulatory submission and biodefence readiness.

Optiscan Imaging has reached the halfway recruitment milestone in its first in-human breast cancer study, advancing its regulatory and commercial ambitions with promising clinical data and expanded trial sites.

ReNerve has inked an exclusive three-year deal with Hong Kong’s Swedish Trading Company to distribute its nerve repair products across a vast and dynamic healthcare region.

Amplia Therapeutics has launched a Phase 2b trial testing a new daily dosing regimen of narmafotinib combined with chemotherapy in advanced pancreatic cancer, aiming to accelerate progress towards a pivotal Phase 3 study.

Lumos Diagnostics has reached a key enrolment milestone in its BARDA-backed FebriDx paediatric trial, unlocking a US$670,000 payment and advancing its FDA submission pathway to expand use in children aged 2-12 years.

AdAlta has secured A$2.5 million in a strategic placement to push its lead CAR-T therapy BZDS1901 through critical US FDA regulatory steps and establish Australian manufacturing, building on promising clinical responses in advanced mesothelioma.

ReNerve Limited reports a 79% jump in quarterly sales, secures key Asia-Pacific approvals, and progresses its nerve repair pipeline with the NervAlign Nerve Guide Matrix entering Stage 3 development.

Artrya has fully integrated its Salix platform at Tanner Health, is preparing two more US sites for launch, and is finalising FDA submission for its Coronary Flow module, backed by a strong cash position of $76.6 million.