Latest Us Fda News

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.

AdAlta expects an additional R&D Tax Incentive refund of more than A$1 million after securing approval for specified overseas work on its EW-001 CAR-T therapy. The cash benefit arrives as the company prepares for a US FDA pre-IND meeting in November.

Bubs Australia delivered 9.2% revenue growth and a sharp underlying EBITDA improvement in FY26, but statutory losses, weaker margins and negative operating cash flow expose the cost of its expansion. Permanent US FDA authorisation removes a major regulatory hurdle, while the annual report still flags material uncertainty around ongoing funding and cash generation.

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.

Memphasys has reported record September-quarter invoiced revenue of A$211,000 as its Felix fertility device moves into more international markets. The commercial progress comes alongside A$3.5 million in funding, but the loan still requires shareholder approval for conversion into notes.

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.

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.

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.

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.

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.

Nexsen has paused its StrepSure clinical programme after an interim review identified performance improvements needed before a US FDA submission, pushing the target timetable back by roughly one quarter. Its shares were then suspended pending an announcement about a potentially material contract for an additional device.

Prescient Therapeutics has raised approximately $6 million through its Share Purchase Plan and a shortfall placement, giving PTX-100 additional funding beyond a key clinical review in December. The next test is whether early results support a move into Phase 2b development.