Latest Us Fda News

AdAlta’s partner SHcell has gained regulatory approval to provide the BZDS1901 CAR-T therapy to advanced mesothelioma patients in China’s Hainan Boao Lecheng special access zone, marking a key milestone in real-world data collection and treatment availability.

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.

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.

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.

Acrux Limited reported a 46% revenue increase to $6.6 million in FY26, driven by US generic product royalties and licensing milestones, while narrowing its net loss by 90%. The company is pivoting towards developing a female testosterone therapy with encouraging Phase II data and active regulatory engagement.

Prescient Therapeutics (ASX:PTX) has opened a $7 million Share Purchase Plan at a significant discount to advance its lead cancer therapy PTX-100 beyond a pivotal Dose Optimisation Committee review in late 2026.

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

Prescient Therapeutics launches a $7 million Share Purchase Plan at an 18.8% discount to fund advancement of its PTX-100 cancer therapy beyond a key 2026 Dose Optimisation Committee review.

AdAlta Limited (ASX:1AD) has progressed its ‘East to West’ cellular immunotherapy strategy by securing its first CAR-T asset, advancing Australian manufacturing and US FDA regulatory engagement, while raising A$5.3 million in FY2026 and reporting a net loss of $4.68 million.

Prescient Therapeutics cut its net loss by 4.4% to $7 million in FY26 while expanding its PTX-100 Phase 2a trial across three continents and securing key regulatory designations in Europe and the US.

AdAlta’s lead CAR-T therapy EW-001 continues to demonstrate encouraging survival and response rates in its mesothelioma study, with all patients alive at the latest follow-up and stronger outcomes at higher doses supporting plans for an Australian Phase 1 trial.

Percheron Therapeutics announces Dr Michael Baker as incoming CEO, replacing Dr James Garner who steps down after three years. Baker’s appointment aligns executive incentives with shareholder value as the company prepares for a pivotal HMBD-002 clinical trial.