Latest Fda News

Imugene has secured FDA backing to advance its allogeneic CAR T therapy, azer-cel, into a pivotal Phase 3 trial targeting difficult-to-treat diffuse large B-cell lymphoma (DLBCL), including patients relapsed after prior CAR-T treatment.

Chimeric Therapeutics has won FDA Orphan Drug Designation for its CHM CDH17 CAR-T therapy targeting gastric cancer, advancing its clinical development with regulatory incentives and potential market exclusivity.

Telix Pharmaceuticals has dosed the first patient in the randomized expansion phase of its pivotal ProstACT Global Phase 3 trial for TLX591, targeting advanced prostate cancer. The trial is expanding globally, with regulatory submissions underway in the US and Europe.

Island Pharmaceuticals has been granted a pivotal US patent extending protection for its antiviral drug Galidesivir as a Covid-19 treatment until 2042, reinforcing its strategic position in the antiviral market.

Neurizon Therapeutics has completed manufacturing three GMP registration batches of its lead ALS drug candidate NUZ-001 ahead of schedule, paving the way for FDA submissions and clinical trial enrollment.

Island Pharmaceuticals has submitted critical responses to the FDA, advancing the development of its antiviral Galidesivir under the Animal Rule pathway. The company awaits FDA feedback expected by early January 2026, setting the stage for upcoming Marburg virus studies.

Argenica Therapeutics has demonstrated that its lead drug candidate ARG-007 does not interfere with the clot-busting agent tenecteplase, fulfilling a critical FDA requirement and advancing its stroke therapy development.

Avecho Biotechnology has received patent allowances in the US and Europe for its proprietary CBD soft-gel formulation, reinforcing its intellectual property ahead of pivotal Phase III insomnia trial results expected in mid-2026.

LTR Pharma has secured ethics approval for its Phase II SPONTAN clinical trial, focusing on pharmacokinetics and dosing in men aged 65 and older. Recruitment begins early 2026 with initial results expected mid-year.

Nexsen Limited has appointed internationally acclaimed surgeon-scientist Professor Shekhar Kumta to its board, aiming to fast-track clinical validation and regulatory approval for its rapid diagnostic platforms ahead of a planned 2026 market entry.

Island Pharmaceuticals has secured over $1 million through option exercises by directors and major shareholders, bolstering its cash reserves to advance the clinical and regulatory development of its broad-spectrum antiviral, Galidesivir.

Optiscan Imaging Ltd has initiated Australia’s first intra-operative head and neck cancer imaging study using its advanced InVue® and InForm™ devices, aiming to enhance surgical precision and support FDA regulatory submissions.