Latest Fda News

Immutep has received encouraging feedback from the FDA on its immunotherapy eftilagimod alfa combined with KEYTRUDA for patients with low PD-L1 expression in head and neck cancer, opening potential accelerated approval pathways.

Vitrafy Life Sciences reported a $32.7 million loss for FY25, driven by investments in its next-generation cryopreservation platform following a $35 million IPO and a $4.8 million government grant. The company is progressing commercialization efforts with key partnerships in human and animal health.

Imagion Biosystems has raised A$3.5 million through a placement to fund its Phase 2 clinical trial for HER2+ Breast Cancer in the US, marking a significant step in advancing its proprietary MagSense® imaging technology.

dorsaVi Ltd is expanding its RRAM technology evaluation to next-generation robotics, aiming to deliver sub-millisecond reflexes that could revolutionize safety and dexterity in collaborative robots and wearables.

4DMedical has landed a $10 million strategic investment from Pro Medicus, aimed at accelerating its commercial growth and advancing its CT – VQ™ technology towards FDA clearance in the US.

4DMedical reports a 56% revenue surge in FY25 alongside a strategic $10 million investment from Pro Medicus, advancing its CT, VQ™ lung imaging technology towards FDA clearance.

Optiscan Imaging Ltd has launched its first in-human breast cancer study and unveiled a new veterinary imaging device, while securing a key US collaboration to support FDA submissions.

Clarity Pharmaceuticals has bolstered its cash reserves to approximately $288 million following a $203 million institutional placement, while reporting significant clinical progress across multiple copper-based radiopharmaceutical trials targeting prostate cancer and neuroendocrine tumours.

Cambium Bio has cleared key regulatory hurdles for its lead dry eye disease treatment, Elate Ocular, and strengthened its balance sheet with a $2.12 million placement to support upcoming Phase 3 trials.

Prescient Therapeutics has raised nearly $10 million through a placement and share purchase plan to advance its promising PTX-100 targeted cancer therapy into pivotal clinical stages.

Imugene Limited reports strong clinical progress with its off-the-shelf CAR T therapy azer-cel achieving a 75% overall response rate in Phase 1b trials, alongside new patents and leadership appointments. The company also secured $22.5 million in fresh funding to advance pivotal trials.

Neurotech International reports encouraging Phase I human pharmacokinetic results for its pediatric cannabinoid drug NTI164, alongside published clinical trial data in Rett Syndrome and key regulatory progress in the US and Australia.