Latest Fda News

dorsaVi has secured a new commercial research project with renowned US surgeon Dr. Chirag Patel, leveraging its FDA-cleared wearable sensor technology and AI to enhance injury prevention and performance for elite athletes.

Cardiex has kicked off deliveries of its CONNEQT Pulse arterial health monitors in the U.S., reporting strong preorder momentum and a 150% sales increase in December. The company’s strategic operational shifts and pharma partnerships set the stage for sustained growth in 2025.

Paradigm Biopharmaceuticals has launched a Loyalty and Piggyback Options program aimed at rewarding shareholders and raising up to $111.96 million to support its pivotal Phase III clinical trial.

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.