Latest Fda News

Starpharma has confirmed FDA alignment for its DEP® HER2 first-in-human phase 1 trial, with preparations underway for a mid-2026 start. The biotech also progressed strategic partnerships, published promising data with Genentech, and reported a $14.1 million cash balance alongside rising Viraleze™ sales.

Neurotech International has opened its first Phase 3 clinical site for NTI164 targeting Autism Spectrum Disorder, reported positive 90-day toxicology results, and launched a new Rett syndrome research collaboration.

Mayne Pharma’s third quarter results show modest revenue growth but a sharp improvement in cash flow and earnings, powered by the strong launch of DistributeRx and robust Women’s Health sales.

Cleo Diagnostics (ASX:COV) has hit a major milestone by completing sample collection for its pivotal U.S. ovarian cancer trial, while progressing manufacturing and analytical validation steps toward FDA 510(k) submission.

Actinogen Medical’s pivotal XanaMIA trial clears a key interim hurdle with the Data Monitoring Committee endorsing continuation, while a $16.8 million capital raise and non-dilutive funding bolster its balance sheet ahead of final results due November 2026.

Botanix Pharmaceuticals reported a 5% rise in Sofdra prescriptions in Q3 FY26 despite a dip in net revenue due to insurance deductible resets, strengthened by a $45 million capital raise and a new API supply deal with Piramal.

TrivarX appoints Dr Danielle Meyrick as CEO to spearhead clinical trials and commercialisation of its novel stable isotope MRI brain cancer imaging platform, with Phase 1 studies on track for completion this year.

Argenica Therapeutics is progressing its ARG-007 drug toward a targeted Phase 2b trial for acute ischaemic stroke, leveraging AI for patient selection and securing key regulatory approvals, while maintaining a solid cash position of $8 million.

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

Atomo Diagnostics capitalises on Lumos Diagnostics’ FebriDx FDA CLIA waiver with over $2 million in new sales orders and a $3 million capital raise, expanding its global footprint and product pipeline.

Amplia Therapeutics reported mature ACCENT trial data showing improved survival and multiple complete responses with narmafotinib, alongside a GMP production milestone and CFO appointment.

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.