Latest Drug Approvals News

Island Pharmaceuticals will host a webinar to discuss the FDA's feedback on the clinical development and regulatory approval of its antiviral drug Galidesivir, including key considerations under the FDA's Animal Rule and Priority Review Voucher eligibility.

InhaleRx has secured FDA alignment and ethics approvals to progress clinical trials for its inhaled therapies targeting breakthrough cancer pain and panic disorder, with patient dosing set to begin soon.

Island Pharmaceuticals has completed its acquisition of the broad-spectrum antiviral Galidesivir and is progressing regulatory discussions with the FDA to fast-track approval using the Animal Rule, backed by compelling preclinical data.

Dimerix’s latest PARASOL collaboration analysis reinforces proteinuria as a pivotal endpoint in their Phase 3 FSGS trial, setting the stage for FDA discussions on accelerated approval pathways.

Island Pharmaceuticals has submitted a detailed briefing to the FDA aiming to accelerate approval of its antiviral Galidesivir for Marburg virus under the Animal Rule, with feedback expected by November.

Race Oncology has secured Investigational New Drug approval from South Korea’s regulatory authority, enabling Phase 1 clinical trials of RC220 in combination with doxorubicin for solid tumour patients across four Korean sites.

Island Pharmaceuticals has won a crucial FDA Type C meeting to discuss fast-tracking its antiviral Galidesivir for Marburg virus treatment, with written feedback expected by November.

Island Pharmaceuticals has formally requested a Type C meeting with the US FDA to discuss accelerating approval of its antiviral Galidesivir for Marburg virus using the Animal Rule pathway.

Actinogen Medical reported a $14.7 million net loss for FY25 while progressing its lead drug Xanamem through pivotal Alzheimer’s and depression trials, with interim results expected in January 2026. The company has secured funding through mid-2026 and is preparing for commercialization.

Noxopharm has successfully completed the third dosing phase of its HERACLES trial for SOF-SKN™, confirming safety and moving forward to the highest dose cohort in this pioneering autoimmune drug study.

Island Pharmaceuticals has raised $350,000 through an options exercise by substantial shareholder MWP Partners, reinforcing confidence in its antiviral drug development pipeline.

Tissue Repair Limited reports steady progress in its Phase 3 clinical trials for TR987® despite patient recruitment hurdles, while TR Pro+® sales surge and new distribution deals pave the way for international growth.