Latest Regulatory Affairs News

AdAlta’s subsidiary AdCella has completed its first Joint Development Committee meeting with Shanghai Cell Therapy Group, advancing the development of the CAR-T therapy BZDS1901 with potential timeline acceleration and reduced regulatory risks.

Atomo Diagnostics has responded to an ASX price query following unusual trading activity, denying any undisclosed price-sensitive information while acknowledging a related FDA update involving Lumos Diagnostics.

Nexsen Limited has successfully completed a pivotal FDA Pre-Submission meeting for its StrepSure® diagnostic, significantly reducing regulatory risks and advancing its entry into the large US maternal health market.

Biotron Limited reveals that its lead antiviral candidate BIT-HBV001 shows promising activity against Hepatitis Delta Virus, expanding its potential impact beyond Hepatitis B. Meanwhile, the company completes integration of Sedarex and advances regulatory plans for its anaesthetic SedRx.

Neurotech International has opened the first clinical site for its pivotal Phase 3 trial of NTI164, targeting core symptoms of Autism Spectrum Disorder in children. This milestone marks a key step toward potential regulatory approval and commercialisation.

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.

Aura Energy has postponed its strategic transaction for the Häggån project due to an ongoing Swedish government inquiry into alum shale mining and current market conditions, while retaining full ownership and commitment to the project.

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.

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.

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.

Neuren Pharmaceuticals’ partner Acadia Pharmaceuticals is seeking a re-examination of the European Medicines Agency’s refusal to approve trofinetide for Rett syndrome, aiming to overturn the setback and bring the treatment to European patients.