Latest Fda News

Amplia Therapeutics has secured positive feedback from the US FDA on its Phase 2b/3 trial design for narmafotinib in pancreatic cancer, paving the way for a late 2026 trial start.

ReNerve Limited has raised $3.2 million through a two-tranche share placement to accelerate its sales and marketing efforts in the US and support upcoming product launches, including a new nerve conduit range.

HeraMED has achieved a significant regulatory milestone with the Therapeutic Goods Administration upgrading its HeraBEAT fetal heart rate monitor to Class IIb, making it the only remote home-use device approved in Australia. This positions the company for a potentially lucrative expansion in the Australian maternity care market.

Island Pharmaceuticals has engaged a top Washington DC government affairs firm to accelerate its US biodefence strategy, focusing on its antiviral drug Galidesivir amid promising FDA regulatory signals.

Orthocell Limited reports growing adoption of its Remplir™ nerve repair product in nerve-sparing prostate cancer surgeries across Australia, positioning for a significant U.S. market expansion. The company is investing in research and commercial infrastructure ahead of a medium-term U.S. launch.

AFT Pharmaceuticals delivered a robust first half for FY26, posting 33% revenue growth and a return to profitability, driven by strong Australian sales and recovery in Asia and international markets. The company is advancing its global footprint and R&D pipeline, positioning for sustained growth.

AFT Pharmaceuticals has reported a robust first half of FY26, posting a 33% revenue increase to a record $114.9 million and returning to profitability amid strong growth in Australia and international markets. The company’s advancing R&D pipeline and strategic licensing deals position it well for ambitious FY27 targets.

Dimerix Limited’s ACTION3 Phase 3 trial for DMX-200 in FSGS kidney disease has passed its seventh Independent Data Monitoring Committee review with no safety concerns, reinforcing the drug’s promising safety profile.

Prescient Therapeutics has achieved a key regulatory milestone with the European Medicines Agency granting Orphan Drug Designation for its PTX-100 therapy targeting Cutaneous T-cell Lymphomas, enhancing its commercial and clinical prospects in Europe.

Cyclopharm Limited reaffirms its ambitious target of 250–300 US Technegas installations by late 2026, driven by FDA approval, CMS reimbursement, and a growing pipeline of healthcare sites. The company reports record half-year revenue growth, signaling strong momentum in the expanding lung imaging market.

Biotron Limited has launched a $1.5 million non-renounceable rights issue to fund its strategic acquisition of Sedarex Limited and support ongoing drug development programs. The capital raise follows shareholder approval and aims to diversify Biotron’s portfolio with a next-generation general anaesthetic.

Antaria has disclosed several FDA-identified GMP compliance issues but assures no impact on product quality or supply, committing to expert-led remediation and enhanced training.