Latest Fda News

Cleo Diagnostics reports steady progress in its U.S. and Australian clinical trials for an ovarian cancer blood test, maintaining a solid cash reserve of A$7.3 million as it prepares for FDA submission.

Prescient Therapeutics has secured FDA clearance for its PTX-100 Phase 2 trial targeting relapsed/refractory cutaneous T-cell lymphoma, while also appointing James McDonnell as its new CEO. The company reports steady progress in its cell therapy platforms and maintains a solid cash position bolstered by a recent R&D tax rebate.

Echo IQ confirms the material significance of its pre-submission FDA meeting for EchoSolv HF, marking a pivotal step toward US market entry and commercialisation.

Cambium Bio has secured a A$3 million capital raise and achieved FDA Fast Track status for its lead ophthalmology product, Elate Ocular®, setting the stage for Phase 3 trials in mid-2025.

Clarity Pharmaceuticals reports robust progress in its SECURE trial and secures FDA Fast Track Designation for its diagnostic agent 64Cu-SAR-bisPSMA, underpinning its growth and innovation in prostate cancer treatment.

Tissue Repair Limited reports initial patient enrolment in its pivotal Phase 3 trial for TR987®, alongside a robust 35% quarterly sales increase for its TR Pro+® product. The company is also advancing manufacturing and distribution strategies to support growth.

Arovella Therapeutics has bolstered its financial position with a $20 million placement, fully funding the Phase 1 clinical trial of its lead CAR-iNKT therapy, ALA-101, targeting CD19-positive blood cancers. The company also established a Clinical Advisory Board and anticipates key regulatory and clinical milestones in 2025.

Nova Eye Medical Limited is raising A$6.6 million to strengthen its financial position following resolved supply chain disruptions, while reporting strong sales growth and nearing profitability in its glaucoma division.

Prescient Therapeutics has secured FDA clearance to initiate its Phase 2 PTX-100 trial for relapsed cutaneous T-cell lymphoma, alongside progress in its cell therapy platforms and a solid cash position bolstered by a recent R&D rebate.

Visioneering Technologies reported a mixed Q4 FY'24 with a slight revenue decline but stronger cash flow and expanding global footprint, underpinned by promising clinical trial data.

Mesoblast Limited is set to launch Ryoncil®, the first FDA-approved MSC therapy for pediatric steroid-refractory acute graft-versus-host disease, backed by a recent $160 million financing that strengthens its commercial and clinical development efforts.

Mesoblast has secured FDA approval for Ryoncil®, the first mesenchymal stromal cell therapy for steroid-refractory acute graft versus host disease in children, while raising A$260 million to accelerate clinical trials and commercial rollout.