Latest Regulatory Affairs News

Neurizon Therapeutics has secured a critical five-year supply agreement with Elanco Animal Health for GMP-grade monepantel, underpinning the commercialisation readiness of its lead ALS drug candidate NUZ-001.

Island Pharmaceuticals has presented encouraging Phase 2a results for its dengue antiviral ISLA-101, demonstrating safety, effective blood concentrations, and meaningful viral load reductions at the Asia Dengue Summit.

Echo IQ has partnered with Mayo Clinic to assess its AI platform's ability to predict heart failure risk in patients undergoing cancer therapy, targeting the growing cardio-oncology sector.

Emyria Limited is progressing its national network of psychedelic-assisted therapy clinics, reporting durable patient outcomes, expanding funding sources, and benefiting from regulatory changes that broaden therapist eligibility.

Argenica has completed the last FDA-mandated cardiac safety assay for its stroke drug ARG-007, paving the way to lift the clinical hold and initiate Phase 2b trials in the US.

Island Pharmaceuticals has kicked off GMP manufacturing of its antiviral Galidesivir to support late-stage Marburg virus studies under the FDA Animal Rule, marking a key step towards regulatory submission and biodefence readiness.

Amplia Therapeutics reported encouraging mature data from its ACCENT pancreatic cancer trial showing improved survival and response rates with narmafotinib. The company raised $27.5 million to fund development and manufacturing scale-up, while discontinuing a parallel trial due to chemotherapy toxicity.

PolyNovo has completed its pivotal US clinical trial report for NovoSorb BTM and adjusted its FDA Premarket Approval submission timeline to late 2026 to incorporate updated regulatory requirements and additional data.

Actinogen Medical has obtained positive scientific advice from the European Medicines Agency that aligns with prior FDA guidance, clarifying regulatory requirements for its Alzheimer’s drug Xanamem and paving the way for a streamlined approval process in major markets.

Cryosite Limited delivered a robust 22% revenue increase and 28% EBITDA growth for the ten months to April 2026, powered by expanding clinical trial activity and infrastructure upgrades.

AdAlta has engaged specialist advisors to streamline US FDA regulatory processes for its CAR-T therapy BZDS1901, which has shown rare complete tumour clearance in advanced mesothelioma patients.

Island Pharmaceuticals has appointed Raymond Taylor, a former BioCryst executive with deep Galidesivir expertise and US government funding experience, to accelerate development and procurement efforts for its broad-spectrum antiviral amid rising viral threats.