Latest Pharmaceuticals News

Island Pharmaceuticals has won a key regulatory boost as the US FDA granted Orphan Drug Designation to Galidesivir for post-exposure prophylaxis of Marburg virus disease, enhancing its commercial and development prospects.

CLINUVEL Pharmaceuticals has lodged its Form 20-F with the U.S. SEC, seeking to elevate its American Depository Receipt program to a Nasdaq-listed American Depository Share, aiming to boost visibility and liquidity without raising capital.

LTR Pharma has confirmed it disclosed a binding US commercialisation agreement for ROXUS promptly after signing, responding to ASX scrutiny over pre-announcement trading activity.

Paradigm Biopharmaceuticals has completed enrolment ahead of schedule in its pivotal Phase 3 trial for Zilosul®, enrolling 538 patients with knee osteoarthritis and maintaining its timeline for interim and final results.

Island Pharmaceuticals is accelerating development of its broad-spectrum antiviral Galidesivir, progressing clinical, regulatory, and manufacturing milestones under the FDA Animal Rule pathway with expanded USAMRIID collaboration and biodefence positioning.

LTR Pharma has locked in Strive Specialties as its exclusive US pharmacy fulfilment partner for ROXUS, marking a critical step towards commercial launch in the US erectile dysfunction market.

Island Pharmaceuticals has expanded its partnership with USAMRIID to conduct a pivotal Galidesivir dose optimisation study against Marburg virus, targeting topline results in the second half of 2026.

LTR Pharma has secured a binding US telehealth commercialisation framework for its intranasal erectile dysfunction treatment ROXUS, committing to at least 150,000 prescriptions in the first year and granting exclusivity to Shed Holdings' platform.

Mayne Pharma has received $14.4 million from Cosette Pharmaceuticals covering legal costs and interest following a Supreme Court ruling in its favour. The legal battle continues with Cosette’s appeal decision pending.

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.

Acrux has locked in a milestone-based licensing agreement worth up to AUD 5.4 million for Lenzetto®, targeting the Australian menopause therapy market with regulatory and commercial milestones tied to TGA approval and sales performance.

Acrux has amended its licensing agreement with Gedeon Richter to bring its Estradiol spray Lenzetto® to Australia, unlocking up to AUD 5.4 million in milestone payments and addressing a critical shortage in Menopause Hormone Therapy products.