Latest Fda News

Island Pharmaceuticals has reported encouraging Phase 2a/b trial results for ISLA-101, demonstrating meaningful reductions in dengue viral load and symptoms in humans. The findings support further clinical development of this antiviral candidate.

dorsaVi has secured exclusive worldwide rights to cutting-edge RRAM technology from NTU Singapore, promising to revolutionize its wearable sensor products with enhanced performance and energy efficiency. This strategic move positions the company for expansion into healthcare, elite sports, and industrial IoT markets.

Cleo Diagnostics unveils a pioneering blood test for early ovarian cancer detection, boasting superior accuracy to existing methods and targeting a significant U.S. market opportunity.

Telix Pharmaceuticals showcased its global theranostic radiopharmaceutical portfolio, highlighting FDA approvals, clinical progress, and a robust commercial expansion plan at its 2025 Investor Day.

Radiopharm Theranostics has secured FDA Fast Track designation for RAD101, a novel imaging agent aimed at improving diagnosis of recurrent brain metastases. The move could speed development and regulatory review as the company advances its Phase 2 clinical trial.

Cyclopharm Limited has secured the maximum five-year U.S. patent extension for its flagship Technegas® Kit, extending market exclusivity to 2031 and reinforcing its strategic foothold in pulmonary imaging.

Syntara Limited’s lead drug candidate SNT-5505 has secured FDA Fast Track designation, expediting its development for treating myelofibrosis, a rare and serious blood cancer with limited therapies.

Argenica Therapeutics faces a clinical hold from the US FDA on its stroke drug trial application, though its Australian Phase 2 study remains unaffected and on track.

Botanix Pharmaceuticals has secured a US$30 million debt facility from Kreos Capital, bolstering its financial position to commercialize Sofdra™ and pursue platform expansion opportunities.

EBR Systems has completed the first commercial US implants of its FDA-approved WiSE wireless cardiac resynchronization therapy system, marking a pivotal step toward broader market adoption and reimbursement.

Clarity Pharmaceuticals reports that its Cu-SARTATE diagnostic agent significantly outperforms the current standard in detecting neuroendocrine tumours, paving the way for a pivotal Phase III study.

PainChek has advanced its US regulatory approval process with a positive FDA meeting, setting the stage for a potential market debut of its pain assessment app in late 2025.