Latest Regulatory Affairs News

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.

Prescient Therapeutics has achieved a key regulatory milestone with the European Medicines Agency granting Orphan Drug Designation for its PTX-100 therapy targeting Cutaneous T-cell Lymphomas, enhancing its commercial and clinical prospects in Europe.

Biotron Limited has launched a $1.5 million non-renounceable rights issue to fund its strategic acquisition of Sedarex Limited and support ongoing drug development programs. The capital raise follows shareholder approval and aims to diversify Biotron’s portfolio with a next-generation general anaesthetic.

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.

NeuroScientific Biopharmaceuticals has initiated treatment of its fourth patient under the Special Access Scheme for StemSmart™, progressing towards a Phase 2 trial targeting severe Crohn’s disease.

Mesoblast is set to meet the FDA in December to discuss compelling Phase 3 data showing its cell therapy rexlemestrocel-L may significantly reduce opioid use in chronic low back pain patients. This meeting could mark a pivotal step in addressing the US opioid crisis through innovative regenerative medicine.

InhaleRx has secured FDA alignment and ethics approvals to progress clinical trials for its inhaled therapies targeting breakthrough cancer pain and panic disorder, with patient dosing set to begin soon.

Recce Pharmaceuticals has commenced patient dosing in its pivotal Phase 3 trial for diabetic foot infections in Indonesia, supported by promising antibacterial efficacy data and extended funding arrangements.

Cleo Diagnostics has secured positive FDA feedback and nearly 1,600 biobank samples, accelerating its ovarian cancer blood test development ahead of a planned 2026 U.S. market entry.