Latest Fda Approvals News

Mesoblast has entered agreements to issue up to US$50 million in convertible notes, aiming to strengthen its capital base and support pipeline growth, pending shareholder approval.

Botanix Pharmaceuticals posted a sharp revenue increase driven by its new hyperhidrosis treatment Sofdra, yet reported a substantial net loss reflecting heavy investment in commercialisation. The company’s strong cash position underpins its path to profitability.

Singular Health Group reported a $6.38 million loss for FY2025 while securing a pivotal $1.3 million commercial agreement with US-based Provider Network Solutions to deploy its 3DICOM software. The company also completed a major cloud migration of its platform, positioning itself for growth in the US healthcare market.

Cambium Bio reported a $3.84 million loss for FY25 but secured critical FDA approvals and ethics clearances to initiate Phase 3 trials of Elate Ocular®, supported by a $2.12 million capital raise.

Paradigm Biopharmaceuticals marked FY25 with the launch of its global Phase 3 trial for its osteoarthritis drug iPPS, backed by strong FDA protocol approval and a $41 million funding facility. The company also broadened its pipeline with the acquisition of Pentacoxib™, targeting early-stage OA.

Neurotech International reported a 23% revenue drop and a doubling of its net loss to $10.6 million for FY25, driven by reduced R&D grants and high development costs. Despite financial pressures, the company marked significant clinical and regulatory progress for its NTI164 cannabinoid therapy.

Bubs Australia Limited reports a striking turnaround in FY25 with revenue up 29% to $102.5 million and net profit soaring 124% to $5.17 million, driven by strong US and China growth. The company awaits permanent FDA approval, a pivotal factor for its future trajectory.

Acrux Ltd reported a 44% revenue decline and a modest increase in net loss for FY25, while expanding its US topical generics portfolio and entering the Saudi Arabian market. The company signals a strategic pivot amid intensifying competition and lower returns.

Mesoblast Limited marked a transformative year with FDA approval and commercial launch of Ryoncil, its first mesenchymal stromal cell therapy, driving a 191% jump in cell therapy revenues. The company is now poised to expand its footprint in inflammatory diseases with multiple clinical trials and label extensions underway.

Mesoblast reports a strong FY2025 financial performance driven by the commercial launch of Ryoncil, the first FDA-approved mesenchymal stromal cell therapy for steroid-refractory acute graft-versus-host disease in children. The company is advancing multiple clinical programs targeting inflammatory diseases, heart failure, and chronic low back pain.

Mesoblast Limited has reported its FY2025 results, highlighting the FDA approval and US commercial launch of Ryoncil, its first mesenchymal stromal cell therapy, alongside a $102.1 million net loss and $161.6 million in cash reserves.

BlinkLab Limited reported a substantial net loss of $5.7 million for FY2025, driven by intensive R&D and clinical trial activities, while securing $7.66 million in fresh capital to fuel its smartphone-based neurodevelopmental diagnostic platform targeting autism and ADHD.