Latest Fda Review News

NeuroScientific Biopharmaceuticals (ASX:NSB) has locked in a key FDA Pre-IND meeting for late August, advancing its Phase 2 trial plans for StemSmart™ targeting refractory Crohn’s disease in the US and Australia.

OncoSil Medical reported a 53% increase in unit sales and advanced key regulatory approvals, including FDA final review and TGA listing, positioning it for growth in pancreatic cancer treatment.

AFT Pharmaceuticals secures tentative FDA approval for Scomara cream to treat rare facial tumours but faces a US launch delay due to orphan drug exclusivity. The approval bolsters prospects in other markets where AFT expects competitive advantages.

OncoSil Medical has submitted its Humanitarian Device Exemption application to the FDA for its OncoSil™ device targeting distal cholangiocarcinoma, entering the final review phase with a decision expected within 45 days.

Mesoblast has received a Biologics License Application filing number from the FDA for rexlemestrocel-L, targeting life-threatening bleeding in end-stage heart failure patients with LVADs, advancing its regulatory journey with orphan drug and RMAT designations.

Echo IQ has locked in a binding Heads of Agreement with Pro Medicus for a strategic A$20 million investment and a US commercial partnership to accelerate adoption of its AI-powered cardiac diagnostic platform.

Imricor Medical Systems has submitted the third of four Premarket Approval modules to the FDA, marking a key step towards US approval of its MR-guided cardiac ablation devices.

OncoSil Medical has cleared a major regulatory hurdle as its Humanitarian Device Exemption application nears FDA approval, while its TRIPP-FFX trial shows promising results combining OncoSil with standard chemotherapy for pancreatic cancer.

Bubs Australia expects FY26 revenue between $105 million and $115 million, with underlying EBITDA forecast at $4 million to $8 million despite external challenges including regulatory delays and increased air freight costs.

LTR Pharma highlights SPONTAN's 5x faster absorption and validated safety, backed by over 1,000 Australian prescriptions and strategic partnerships as it targets FDA approval and US market entry.

Syntara Limited has raised A$10 million through a two-tranche placement and share purchase plan, backing its Phase 2b myelofibrosis trial and multiple clinical readouts following positive FDA feedback.

Telix Pharmaceuticals has initiated a US$550 million convertible bonds offering to refinance existing 2029 bonds and support general corporate purposes, securing low-cost, non-dilutive financing with a conversion premium above current share price.