Latest Fda News

Argent BioPharma has locked in an A$11 million convertible financing facility to finalize its strategic acquisition of AusCann assets and accelerate its growth plans, including a potential US stock exchange listing.

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.

Race Oncology has announced pivotal new clinical trials for its lead asset RC220, aiming to accelerate regulatory approval in Acute Myeloid Leukemia and tackle resistance in Non-Small Cell Lung Cancer.

Radiopharm Theranostics has reached the halfway mark in enrolling patients for its Phase 2b trial of RAD101, a novel imaging agent targeting brain metastases. Early data suggest RAD101 may outperform MRI in distinguishing tumor recurrence from radiation damage.

PYC Therapeutics reports sustained vision improvements in patients with Retinitis Pigmentosa type 11 treated with VP-001, showing promising safety and efficacy up to 18 months. The company plans to engage the FDA in early 2026 to finalize pivotal trial design.

Island Pharmaceuticals will host a webinar to discuss the FDA's feedback on the clinical development and regulatory approval of its antiviral drug Galidesivir, including key considerations under the FDA's Animal Rule and Priority Review Voucher eligibility.

Resonance Health has revealed ambitious growth plans at its 2025 AGM, projecting revenue to nearly quadruple by FY26 while maintaining positive EBITDA guidance. The company is broadening its global footprint and diversifying its clinical trial services across multiple therapeutic areas.

Anteris Technologies has gained FDA approval to start patient recruitment in the US for its pivotal PARADIGM Trial, following initial European regulatory success. The company advances manufacturing and clinical readiness as it pushes toward key regulatory milestones.

Anteris Technologies Global Corp. reported a $22.2 million loss in Q3 2025 while progressing its DurAVR Transcatheter Heart Valve pivotal trial following key regulatory approvals. The company bolstered its cash position with a $25.2 million private placement post-quarter.

EBR Systems has achieved a major commercial milestone with Medicare reimbursement approvals for its wireless cardiac pacing WiSE CRT System, driving a 201% revenue increase in Q3 2025. The company is advancing its Limited Market Release as it scales adoption in the US.

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.