Latest Fda News

4DMedical lands a contract with pharma giant GSK, gains UKCA certification for its CT:VQ™ lung imaging technology, and joins the S&P/ASX 200, marking a significant step in its global expansion.

Patrys has raised A$3.2 million through a share placement to fund its injectable quetiapine program’s Phase 1A clinical trial and FDA pre-IND preparations.

Atomo Diagnostics has responded to ASX queries confirming it first held market-sensitive information after Lumos Diagnostics’ FDA CLIA waiver approval for FebriDx. The company defended its trading halt and capital raise timing, asserting full compliance with ASX Listing Rules.

Immuron Limited’s unaudited Q3 FY26 sales rose 16% to AUD 1.5 million, driven by Travelan’s expanding footprint in Australia, Canada, and the US despite a stronger Australian dollar.

BlinkLab has secured A$17.5 million through an oversubscribed placement to fuel regulatory trials and commercial launch of its AI-driven autism and ADHD diagnostic tools.

Botanix Pharmaceuticals has agreed to terms with Piramal to establish an alternate supplier for the active ingredient in Sofdra, aiming to reduce costs by up to 40% and strengthen its supply chain.

Radiopharm Theranostics has finished enrolling patients in its U.S. Phase 2b trial of RAD 101 for brain metastases imaging, reporting promising interim data showing 90% concordance with MRI. The company aims to launch a pivotal Phase 3 trial following a full data readout in June 2026.

ReNerve has moved its NervAlign Nerve Guide Matrix into stage 3 of commercial development, a key step toward FDA submission and eventual market entry. This progress supports the company’s ambition to provide surgeons with an alternative to donor nerves for repairing severe peripheral nerve injuries.

Immutep Limited has won FDA Orphan Drug Designation for its immunotherapy eftilagimod alfa in treating soft tissue sarcoma, opening regulatory incentives and potential market exclusivity. This follows encouraging Phase II data despite recent Phase III trial setbacks.

Mesoblast has acquired exclusive rights to a patented chimeric antigen receptor platform designed to enhance the targeting and potency of its mesenchymal stromal cell therapies, aiming to expand treatment options for inflammatory and autoimmune diseases.

Nyrada has secured ethics approval to start its Phase IIa trial of Xolatryp in heart attack patients, with recruitment beginning in April 2026. The biotech also bolsters its cash position to AU$6.74 million and pursues new oncology indications.

AVITA Medical’s Cohealyx-I study interim results show a significant acceleration in skin grafting time for full-thickness wounds, reducing mean time to graft from 33.2 to 13.6 days. The ongoing trial’s promising data could reshape wound care protocols.