Latest Fda News

Mesoblast has reported a sharp first-quarter commercial improvement, with Ryoncil revenue rising 44% and net operating cash spend falling 85% year on year. The company ended September with US$99 million in cash, although the figures remain preliminary.

Mayne Pharma has settled its final US Paragraph IV patent dispute over IMVEXXY with Teva, setting a potential generic entry date of 2 September 2032. The agreement removes ongoing litigation without an upfront payment, while leaving court approval and earlier-entry provisions to resolve.

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.

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.

Cleo Diagnostics has moved its pre-surgical ovarian cancer test into formal Analytical Validation, a key regulatory step before its planned FDA 510(k) submission in the first half of 2027. The three-batch program is expected to take about three months, but no validation results have yet been reported.

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.

Mesoblast has reported a sharp commercial step-up in FY2026, with Ryoncil generating US$115.2 million in net sales and total revenue reaching US$120.3 million. The company has also completed treatment in its 350-patient back-pain trial and refinanced its debt, but remains loss-making and expects to need more capital beyond the next 12 months.

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.