Latest Regulatory Affairs News

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.

Argenica Therapeutics has demonstrated that its lead drug candidate ARG-007 does not interfere with the clot-busting agent tenecteplase, fulfilling a critical FDA requirement and advancing its stroke therapy development.

Pacific Edge appoints Simon Flood as chairman designate, aiming to leverage his global investment expertise to navigate Medicare reimbursement challenges for its bladder cancer diagnostic tests in the US.

Island Pharmaceuticals has secured over $1 million through option exercises by directors and major shareholders, bolstering its cash reserves to advance the clinical and regulatory development of its broad-spectrum antiviral, Galidesivir.

Optiscan Imaging Ltd has initiated Australia’s first intra-operative head and neck cancer imaging study using its advanced InVue® and InForm™ devices, aiming to enhance surgical precision and support FDA regulatory submissions.

Immutep Limited reveals promising Phase II results from its AIPAC-003 trial, establishing 30 mg as the optimal biological dose of eftilagimod alfa combined with paclitaxel in metastatic breast cancer patients.

Tuas Limited reported a robust FY25 with significant revenue and earnings growth, driven by subscriber gains in mobile and fibre broadband. The company is poised for a transformative leap pending regulatory approval of its acquisition of M1 Limited.

SomnoMed Limited reported a robust FY25 with revenue surpassing guidance and a landmark FDA clearance for its Rest Assure® oral device, setting the stage for sustained growth in oral appliance therapy.

InhaleRx Limited has introduced SRX-25, an oral fixed-dose combination therapy targeting Treatment-Resistant Depression, aiming to improve patient access and adherence. The company also secured $1 million in capital to advance clinical development and plans a strategic rebrand.

Syntara Limited has successfully completed Phase 1a trials for its topical anti-fibrotic drug SNT-9465, demonstrating dose-dependent target engagement and safety, and is now progressing to an innovative Phase 1b study in hypertrophic scars.

Clarity Pharmaceuticals has raised $203 million to accelerate its copper-64 and copper-67 radiopharmaceutical pipeline, targeting prostate and neuroendocrine cancers with multiple FDA Fast Track trials underway.

Bougainville Copper Limited reveals complications in its Panguna Project partnership efforts following the Autonomous Bougainville Government's unexpected MOU with Lloyds Metals and Energy Limited.