Latest Regulatory Affairs News

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.

Island Pharmaceuticals has secured membership in the Medical Countermeasures Coalition, positioning its antiviral Galidesivir for critical US government stockpiling and regulatory milestones.

The Foreign Investment Review Board has formally objected to Cosette Pharmaceuticals’ proposed acquisition of Mayne Pharma, casting serious doubt on the deal’s future and prompting Mayne to explore alternative paths.

Amplia Therapeutics has secured positive feedback from the US FDA on its Phase 2b/3 trial design for narmafotinib in pancreatic cancer, paving the way for a late 2026 trial start.

Island Pharmaceuticals has engaged a top Washington DC government affairs firm to accelerate its US biodefence strategy, focusing on its antiviral drug Galidesivir amid promising FDA regulatory signals.

Lake Resources N.L. reports significant progress on its Kachi lithium project, unveiling enhanced project economics and next-generation lithium extraction technology amid a bullish lithium market and supportive Argentine political climate.

Bio-Gene Technology Limited updates on its development of two novel insecticides, Flavocide and Qcide, highlighting regulatory progress, commercial partnerships, and a strong market outlook across multiple sectors.