Latest Fda Approvals News

The FDA's removal of the black box warning on hormone replacement therapies marks a pivotal shift for Mayne Pharma, potentially unlocking new market opportunities and reshaping women’s health treatment.

dorsaVi Limited has acquired a cutting-edge neuromorphic processing-in-memory technology portfolio, positioning itself at the forefront of next-generation wearable and robotics intelligence. This strategic move, coupled with leadership changes, signals a new era for the company’s adaptive biosensor and robotics platforms.

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.

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 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.

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.

Nexsen Limited has successfully completed an $8 million IPO and ASX listing, while advancing its kidney diagnostic tests and initiating clinical trials for its GBS Rapid Sensor targeting expedited FDA approval.

The Treasurer has expressed preliminary concerns that Cosette Pharmaceuticals’ proposed acquisition of Mayne Pharma could harm Australia’s economy, citing plans to close a key Adelaide manufacturing site. Mayne Pharma disputes these claims and urges a resolution before the scheme deadline.

Bubs Australia reported a 30% increase in net revenue to $25.6 million for Q1 FY26, driven by robust US sales and a return to profitability with positive EBITDA. Despite inventory challenges in other regions, the company maintains a solid cash position and anticipates FDA approval by year-end.