Latest Fda Regulation News

Acrux has received clearer FDA guidance for Phase III trials of its female testosterone spray, including potential three-year data exclusivity if the product reaches submission. The company also reported positive September-quarter operating cash flow, but that result was largely driven by a $1.977 million R&D tax rebate and Acrux says it is still pursuing funding for the clinical programme.

Nyrada has moved its PROTECT-MI heart-attack trial into active recruitment, with four hospitals open and three patients dosed. The biotech also reported supportive US FDA feedback, encouraging preclinical oncology data and AU$13.72 million in cash after a AU$12 million placement.

ReNerve has received supportive FDA feedback on the preclinical and testing pathway for its NervAlign Nerve Guide Matrix. The guidance sharpens the route towards a US submission, but does not amount to clearance and leaves the submission timetable open.

The US FDA has supported six of seven elements NeuroScientific Biopharmaceuticals put forward for its planned StemSmart Phase 2 Crohn’s disease trial. The remaining issue is a manufacturing control for viral contamination, while trial commencement remains targeted for the end of 2026 and subject to further requirements.

Nyrada has received supportive written feedback from the US FDA on its proposed pathway for taking Xolatryp into a US Phase IIa heart-attack trial. The regulator identified no major issues, but additional information and stability data are still required before the planned IND submission in the first half of 2027.

Echo IQ has secured an FDA supervisory review of the regulator’s Not Substantially Equivalent decision for EchoSolv HF. The review creates a formal route for reconsideration, but does not change the current regulatory determination or guarantee clearance.

Acrux says the FDA has confirmed the evidence package required to take its female testosterone spray into Phase III trials for postmenopausal women with HSDD. The agency also indicated the company may apply for three years of data exclusivity if the product reaches submission.

EBR Systems reported 40 WiSE commercial implants in Q3, down from 46 in Q2 and below its prior forecast, as leadership changes and a sales strategy reset disrupted activity. Higher Medicare reimbursement and progress at its new manufacturing facility offer potential offsets, but both remain dependent on execution and regulatory approval.

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.

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.