Latest Drug Approvals News

Island Pharmaceuticals has completed its acquisition of the broad-spectrum antiviral Galidesivir ahead of schedule, setting sights on expedited FDA approval leveraging the Animal Rule.

InhaleRx Limited has secured key ethics approvals and initiated manufacturing for its inhaled drug candidates targeting breakthrough cancer pain and panic disorder, supported by a $38.5 million funding facility to accelerate development.

PYC Therapeutics reports solid progress across its four RNA therapeutic programs targeting genetic diseases, backed by a strong cash position extending runway beyond 2027.

Island Pharmaceuticals has accelerated its acquisition of the Galidesivir antiviral program from BioCryst Pharmaceuticals, adding a clinically advanced asset with significant US government backing and a promising regulatory pathway.

PYC Therapeutics has gained FDA alignment on the design of its pivotal Phase 2/3 trial for VP-001, a promising treatment for the rare childhood blindness RP11. The regulator accepted the trial’s sham control arm and primary endpoints, setting the stage for a critical next step toward drug approval.

Bioxyne Limited, through its subsidiary Breathe Life Sciences, has secured a significant supply agreement to enter Germany’s burgeoning medical cannabis market, promising at least A$5.6 million in revenue for FY2026.

Argent BioPharma reports significant operational savings through manufacturing outsourcing, encouraging Phase IIb results for CimetrA®, and key regulatory approvals for cannabinoid therapies in Germany.

PYC Therapeutics has secured regulatory approval to initiate human trials of PYC-003, a novel drug candidate targeting the root cause of Polycystic Kidney Disease (PKD). Initial safety and efficacy data are expected within 2025, marking a critical step in addressing a disease affecting millions worldwide.

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.

Island Pharmaceuticals reports promising safety and anti-dengue activity in its Phase 2a trial of ISLA-101 and has commenced the Phase 2b therapeutic arm, backed by a fresh A$3.5 million capital raise.

InhaleRx has corrected its quarterly report and revealed a $38.5 million funding deal to fast-track clinical trials for its inhaled therapies targeting breakthrough cancer pain and panic disorder, aiming for FDA approval.