Latest Fda News

Imricor has completed FDA review of the largest module in its US Premarket Approval application, with no deficiencies found in its ablation catheter or irrigation tubing. One operating-system issue remains for the RF-5000 System, but the company says it has already updated the software and is preparing its response.

Noxopharm says the FDA has supported its proposed Phase II design and chemical manufacturing strategy for SOF-SKN, its topical treatment candidate for cutaneous lupus erythematosus. The feedback improves regulatory clarity, but the trial remains targeted for the first half of calendar 2028 and is subject to further studies and regulatory requirements.

The FDA says positive results from Neurizon’s HEALEY ALS trial could potentially support traditional approval of NUZ-001, with the study possibly serving as the sole registrational trial. The guidance is conditional, but gives the company a clearer regulatory route ahead of topline results expected in late Q2 2027.

Neurotech International has moved NTI164 into a registration-enabling Phase III autism trial, but its annual report carries a material going-concern warning. The company says post-year-end debt and equity funding should support the program through topline data, subject to execution and completion.

ReNerve’s October AGM presentation points to sharply higher sales, a growing US distribution network and a broader nerve repair pipeline. The company is also progressing a 240-patient NervAlign clinical study while relying on a $5 million RiverFort funding facility to support expansion.

Optiscan Imaging has lodged a US FDA 510(k) application for InVue, its precision surgery device designed to provide cellular-level imaging during operations. The submission moves the technology into formal regulatory review, but clearance and commercialisation remain uncertain.

Radiopharm says the FDA has provided a clear framework for the pivotal development of RAD101, its investigational brain metastases imaging agent. The company is preparing for Phase 3 while awaiting formal meeting minutes that could still refine the trial design and regulatory requirements.

AdAlta and Shanghai Cell Therapy Group have approved the FDA briefing pack and manufacturing transfer plan for EW-001, bringing the mesothelioma CAR-T therapy closer to an Australian Phase 1 trial. The FDA meeting is scheduled for November, while two Chinese patients remain under follow-up, including a second complete responder.

Island Pharmaceuticals has begun GMP production of Galidesivir, with the first 5kg batch targeted for an investigational Ebola treatment program in Uganda. A second batch is intended to support a pivotal Marburg animal study under the FDA’s Animal Rule pathway.

Artrya has signed a five-year agreement with Huntsville Hospital Health System, converting the first participant in its SAPPHIRE Study into a commercial customer. The deal carries a minimum contracted value of US$0.5 million for Salix Coronary Anatomy, with further usage-based revenue possible from other modules.

Optiscan Imaging has lodged a 510(k) submission for its InForm digital pathology device, moving the product from development into formal US regulatory assessment. FDA clearance is not assured, but a successful determination could open the door to commercial distribution in the company’s target market.

LTR Pharma has completed the final Phase II pharmacokinetic report for SPONTAN, confirming a median 10-minute time to peak concentration against 60 minutes for an oral vardenafil tablet. The result completes the FDA-aligned dataset ahead of planned US submission work, although efficacy in erectile dysfunction patients remains to be tested.