Latest Fda News

Dimerix Limited is set to conduct a blinded statistical review of its pivotal Phase 3 ACTION3 study in March 2026, aiming to confirm the trial remains powered to demonstrate the primary endpoint of proteinuria reduction in FSGS patients.

Telix Pharmaceuticals has resubmitted its New Drug Application to the FDA for TLX101-Px (Pixclara®), aiming to advance a novel PET imaging agent for glioma diagnosis. The resubmission addresses prior regulatory concerns with additional data, reinforcing hopes for expedited approval.

Tetratherix Limited launches a new precision medicine franchise leveraging its Tetramatrix™ platform, securing a decade-long exclusive partnership with US health group Superpower Health Inc. This deal promises immediate revenue and complements ongoing FDA milestones.

Acrux Limited has secured a $0.55 million advance on its FY26 R&D Tax Incentive, providing crucial funding to accelerate development of its Hormone Replacement Therapy following FDA regulatory confirmation.

Patrys has initiated manufacturing and regulatory steps for RLS-2201, its injectable Quetiapine formulation targeting delirium, aiming for Phase 0 trials in the second half of 2026.

Dimerix Limited has completed dosing of the last adult patient in its ACTION3 Phase 3 trial for DMX-200, exceeding its recruitment target and setting the stage for key regulatory milestones.

Tetratherix Limited has raised approximately $5 million to fast-track its Tutelix prostate spacer into pivotal clinical trials across Australia and the US, aiming to improve radiation therapy for prostate cancer patients.

Clarity Pharmaceuticals has completed enrolment in its Phase III AMPLIFY trial for the Cu-SAR-bisPSMA imaging agent, advancing its bid for FDA approval in prostate cancer diagnostics.

Telix Pharmaceuticals has announced that Part 1 of its ProstACT Phase 3 trial for TLX591-Tx met its primary safety and dosimetry objectives, with no new safety concerns. The study’s success supports ongoing global enrolment in Part 2 and regulatory engagement in the US.

LTR Pharma has finalised recruitment for its Phase II clinical trial of SPONTAN, a rapid-acting intranasal spray for erectile dysfunction, with initial results expected in the second quarter of 2026.

Nexalis Therapeutics has initiated its Phase 1 trial for IRX-616a, an inhaled cannabidiol treatment aimed at panic disorder, marking a significant step in developing rapid-onset anxiety therapies.

Island Pharmaceuticals has entered a pivotal research agreement with USAMRIID and the Geneva Foundation to accelerate FDA approval of Galidesivir for Marburg Virus Disease, leveraging top-tier US biodefense expertise.