Latest Drug Approvals News

Vertex has raised its full-year 2026 revenue guidance after third-quarter sales climbed 12%, but the Crinetics acquisition sharply increased costs and debt. The next major test arrives on 30 November, when US regulators are due to rule on povetacicept for IgA nephropathy.

Tissue Repair has increased its US Phase III chronic wound trial to approximately 112 randomised patients while shifting focus towards an April 2027 FDA 510(k) submission. The company also reported $4.74 million in cash, Australian availability of all three TR Pro+ formats and a planned $1 million share buy-back.

Island Pharmaceuticals has entered a pivotal research agreement with USAMRIID and the Geneva Foundation to accelerate FDA approval of Galidesivir for Marburg Virus Disease, leveraging top-tier US biodefense expertise.

Island Pharmaceuticals reports a 213.8% increase in half-year loss to $4.81 million, driven by strategic acquisition and clinical development investments. The company advances its antiviral portfolio with Galidesivir and ISLA-101, supported by strong US regulatory engagement and a $9 million capital raise.

Island Pharmaceuticals has confirmed the material significance of recent FDA feedback on its Galidesivir development pathway and addressed ASX queries on disclosure timing and capital raising activities.

Island Pharmaceuticals secures FDA confirmation on Galidesivir’s development under the Animal Rule, unlocking a streamlined two-stage approval process and significant commercial incentives.

Acadia Pharmaceuticals has received a negative vote from the European Medicines Agency’s committee on its application to market trofinetide for Rett syndrome in the EU, prompting plans for a re-examination request.

InhaleRx Limited has progressed its clinical trials for three drug candidates targeting cancer pain, panic disorder, and treatment-resistant depression, while securing additional funding and preparing for a company rebrand.

Island Pharmaceuticals reports ongoing FDA review of its antiviral Galidesivir, with no adverse feedback received as the regulator takes extra time to finalise guidance.

Island Pharmaceuticals has submitted critical responses to the FDA, advancing the development of its antiviral Galidesivir under the Animal Rule pathway. The company awaits FDA feedback expected by early January 2026, setting the stage for upcoming Marburg virus studies.

Alterity Therapeutics announces significant board changes, including the retirement of founding chairman Geoffrey Kempler and appointment of CEO Dr David Stamler as Managing Director, aligning leadership with its Phase 3 clinical ambitions.

Island Pharmaceuticals has secured FDA confirmation that its antiviral Galidesivir can proceed under the Animal Rule pathway for Marburg virus, qualifying for a lucrative Priority Review Voucher. This regulatory milestone accelerates the drug’s path to approval and potential government stockpile inclusion.