Latest Fda News

Patrys Limited has expanded its therapeutic portfolio by acquiring Reliis Pty Ltd, adding a proprietary injectable asset targeting delirium with near-term clinical milestones. This strategic move complements its existing biologics platform and strengthens its financial position.

Nexsen Limited has reported significant progress in its rapid diagnostic technologies, including a key FDA pre-submission for its GBS rapid sensor and a solid cash reserve post-IPO to support commercialisation efforts.

Lumos Diagnostics reported a strong surge in FebriDx® sales alongside positive FDA feedback, securing full Medicare reimbursement and advancing key clinical studies.

Avecho Biotechnology is on the cusp of completing patient dosing in its pivotal Phase III CBD insomnia trial, backed by a recent $2.5 million capital raise and patent allowances in the US and Europe.

InhaleRx Limited has progressed its clinical trials for three drug candidates targeting cancer pain, panic disorder, and treatment-resistant depression, while securing additional funding and preparing for a company rebrand.

Immutep Limited has entered a strategic collaboration with Dr. Reddy’s, receiving a A$30 million upfront payment and potential milestones up to A$528 million, while reporting promising clinical progress across multiple cancer immunotherapy trials.

Mesoblast Limited reported a 60% jump in Ryoncil sales to US$35 million for the December quarter, alongside securing a US$125 million credit facility that enhances its financial flexibility and supports ongoing clinical development.

Syntara Limited has made significant strides in its clinical pipeline, launching new trials and receiving key regulatory designations, positioning 2026 as a pivotal year for the company.

Imagion Biosystems has completed manufacturing its MagSense® HER2 imaging agent and is preparing for a key FDA submission, while appointing a new president to lead its US operations.

Dimerix Limited has completed recruitment for its pivotal ACTION3 Phase 3 trial targeting a rare kidney disease, secured positive FDA feedback on trial endpoints, and reported a solid cash position of AU$38.5 million at the end of 2025.

Zelira Therapeutics has raised nearly US$33 million to fund clinical trials for its HOPE 1 cannabinoid-based medicine targeting autism, while also benefiting from a $1.07 million R&D tax refund.

Biotron Limited has completed the acquisition of Sedarex Limited alongside a $2.5 million capital raising, while its lead Hepatitis B drug candidate BIT-HBV001 shows promising preclinical results outperforming current treatments.