Latest Fda News

Telix Pharmaceuticals has completed enrollment in its pivotal Phase 3 BiPASS trial for prostate cancer imaging and aligned with the FDA on a pathway that could expand U.S. patient access and reimbursement for its 68Ga-PSMA-PET agents.

Actinogen Medical has locked in full underwriting for nearly 127 million unlisted options, guaranteeing $4.77 million in fresh funding as it approaches pivotal Alzheimer’s trial results due in November.

Artrya has launched its AI-powered Salix® platform commercially in the US, securing three foundation health systems and raising $80 million to fuel growth. With FDA clearance for its Coronary Plaque module and a pivotal clinical study underway, the company is poised for scaling revenues amid a strong balance sheet.

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.

Recce Pharmaceuticals narrowed its operating loss to AUD 15 million in FY26, progressing Phase 3 trials for its anti-infective RECCE 327 and securing key patents and commercial partnerships.

Clever Culture Systems expanded its pharmaceutical customer base to eight in FY26, placing 11 APAS Independence instruments and completing its product offering with a contact plate module. Despite a $2.24 million net loss, the company expects meaningful sales growth in FY27 backed by a robust pipeline and disciplined financial management.

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.

Ceretas Limited posted a $1.63 million net loss for FY26 on $1.28 million revenue from government grants, advancing its clinical-stage Alzheimer’s ultrasound platform. The company completed an $8 million IPO in July to fund pivotal trials and device development.

Nexsen Limited (ASX:NXN) reported a 30% rise in net loss to $6.55 million for FY26, driven by ongoing investment in its Group B Streptococcus rapid diagnostic and Asia-Pacific growth initiatives following its October 2025 IPO.

Singular Health Group lifted revenues over fivefold to $1.43 million in FY26, driven by US commercial rollouts of its 3DICOM platform, but posted a $6.34 million loss. The company strengthened its US foothold with FDA clearance and a controlling stake in an associate.

Vectus Biosystems has reported a striking turnaround with a $1.56 million profit for the 2026 financial year, reversing a prior year loss and improving its balance sheet significantly.