Latest Regulatory Affairs News

Syntara Limited reports encouraging interim Phase 2 data for its drug SNT-5505 combined with ruxolitinib, demonstrating significant symptom relief and spleen volume reduction in myelofibrosis patients. The company plans to engage the FDA soon to discuss pivotal trial design.

Mesoblast reports positive FDA progress on accelerated approval for Revascor in ischemic heart failure and plans a pivotal trial to extend Ryoncil’s label to adults with graft versus host disease, while its US commercial launch outpaces expectations.

EVE Health Group has completed its acquisition of Nextract Pty Ltd, positioning itself to enter the lucrative erectile dysfunction and dysmenorrhea markets with innovative drug delivery technologies.

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.

Firebrick Pharma has published its pivotal Phase 3 trial results for Nasodine nasal spray, confirming its effectiveness and safety in treating the common cold, especially when used early.

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.

InhaleRx has secured swift Human Research Ethics Committee approval for its redesigned IRX-211 Phase 2 trial, expanding participant numbers and potentially bypassing Phase 3 to speed market entry.

Recce Pharmaceuticals has completed a A$15.8 million capital raise to fund pivotal Phase 3 clinical trials and progress its FDA application, positioning the company for potential commercial breakthroughs in antibiotic-resistant infections.

INOVIQ Limited has revealed promising data for its EXO-OC™ ovarian cancer screening test, demonstrating exceptional accuracy and flawless detection of early-stage cancers. This innovation could transform early diagnosis and treatment outcomes for women worldwide.

Neurotech International has reported positive human pharmacokinetic results for NTI164, a cannabinoid formulation designed for paediatric neurological disorders, confirming rapid absorption and a non-intoxicating profile.