Latest Fda News

AVITA Medical reported an 18% revenue increase in Q3 2025 driven by new product launches and deeper market penetration, while continuing to face net losses and credit covenant challenges. The company also announced a CEO departure and interim leadership appointment.

Immuron Limited has secured FDA approval for its IMM-529 Investigational New Drug application, clearing the way for a Phase 2 clinical trial targeting Clostridioides difficile infection. This milestone marks a significant step forward for a novel oral antibody therapy addressing a critical infectious disease with high recurrence rates.

Nova Eye Medical reported a 20% year-on-year revenue increase in Q1 FY26, reaffirming its FY26 sales guidance and targeting breakeven EBITDA by June 2026 amid cautious commercial expansion.

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.

Nanosonics Limited has announced a $20 million on-market share buy-back program for FY26, underscoring its robust financial health and confidence in future growth driven by new product innovations.

Imagion Biosystems reports encouraging findings from its Wayne State University collaboration, supporting a lower dose for its MagSense® HER2 imaging agent ahead of a planned FDA IND submission in Q4 2025.

Anteris Technologies has updated the timetable for its Australian capital raising, delaying settlement to November 4 and the start of trading for new securities to November 5. The company also highlights restrictions on U.S. investors acquiring its CDIs.

Anteris Technologies has secured FDA approval to commence its pivotal PARADIGM clinical trial, testing its innovative DurAVR Transcatheter Heart Valve against established devices in patients with severe aortic stenosis.

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.

Acrux Limited reports robust revenue growth in Q1 FY26, driven by strong profit share income from recently launched topical pharmaceuticals and a significant R&D tax rebate repayment.