Latest Fda Regulatory 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.

Alterity Therapeutics has secured official FDA confirmation that a single pivotal Phase 3 trial, backed by prior Phase 2 data, can support approval of ATH434 for Multiple System Atrophy. Trial initiation remains on track for late 2026.

Memphasys has locked in a three-year exclusive distribution agreement for its Felix™ sperm separation system in Thailand, targeting a key IVF market with 110 clinics and 20,000–30,000 cycles annually. The deal adds approximately A$430,500 in contracted revenue, lifting South-East Asian minimum contracts to about A$1 million and contributing to FY2026 Felix™ sales now exceeding A$3 million.

AdAlta has engaged specialist advisors to streamline US FDA regulatory processes for its CAR-T therapy BZDS1901, which has shown rare complete tumour clearance in advanced mesothelioma patients.

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.

Nexsen Limited teams with Universiti Malaya to launch a joint research facility aiming to develop a rapid biosensor detecting E. coli and Salmonella simultaneously, addressing a critical food safety gap in Southeast Asia.

Optiscan Imaging has submitted its FDA dossier for InSpecta®, marking a crucial step toward US veterinary market entry, while progressing clinical studies for InVue® and InForm® ahead of further FDA submissions in 2026.

Acrux pivots from generics to developing a Female Testosterone therapy for HSDD, leveraging FDA feedback and a strong US market opportunity.

Nexsen Limited has cleared a major FDA regulatory hurdle for its StrepSure rapid Group B Streptococcus test, confirmed a clear 510(k) submission pathway, and secured over A$1.7 million in non-dilutive grants to expand clinical validation and market rollout in Asia-Pacific and neonatal diagnostics.

Optiscan Imaging Ltd has taken a significant step towards commercialising its InSpecta® veterinary imaging device in the US by submitting a regulatory dossier to the FDA. This milestone not only initiates formal review but also sets the stage for broader clinical adoption and future device approvals.

Acrux Limited has secured a $0.55 million advance on its FY26 R&D Tax Incentive, providing crucial funding to accelerate development of its Hormone Replacement Therapy following FDA regulatory confirmation.

Cleo Diagnostics reported a 53% drop in revenues and a slight increase in net loss to $1.98 million for H1 2025, while progressing its pivotal FDA clinical trial for an ovarian cancer blood test with strong regulatory and commercial milestones.