Latest Fda Approvals News

Arovella Therapeutics has received a $3.21 million R&D tax incentive refund, bolstering its financial position as it prepares to initiate first-in-human trials for its lead cell therapy, ALA-101.

Imricor Medical Systems has successfully completed a comprehensive Human Factors study for all its devices under FDA review, marking a critical milestone towards U.S. market entry. The extensive 7-month study involved 46 healthcare professionals and tested nine products, underscoring Imricor’s growing momentum in electrophysiology innovation.

EBR Systems has achieved a significant commercial milestone with its tenth US implant of the WiSE wireless cardiac pacing system, setting the stage for broader market adoption supported by new reimbursement schemes.

dorsaVi has inked a five-year sales agreement with Select Medical, opening access to over 1,900 US outpatient physical therapy centers for its FDA-approved motion analysis products. This follows a successful 18-month pilot validating clinical benefits in athlete rehabilitation.

Telix Pharmaceuticals has secured FDA agreement on a resubmission plan for its glioma imaging agent TLX101-CDx, aiming for a Q4 2025 filing that includes additional efficacy data. The FDA signals likely expedited review, underscoring the unmet medical need.

Alterity Therapeutics has raised A$20 million through a strategic placement to advance its promising ATH434 treatment for Multiple System Atrophy, backed by encouraging Phase 2 trial results. The capital injection strengthens the company’s balance sheet as it prepares for regulatory discussions with the FDA.

Botanix Pharmaceuticals’ ECCLOCK® gel, a treatment for excessive sweating, has secured regulatory approval in South Korea, paving the way for a commercial launch in early 2026.

Mesoblast has entered agreements to issue up to US$50 million in convertible notes, aiming to strengthen its capital base and support pipeline growth, pending shareholder approval.

Botanix Pharmaceuticals posted a sharp revenue increase driven by its new hyperhidrosis treatment Sofdra, yet reported a substantial net loss reflecting heavy investment in commercialisation. The company’s strong cash position underpins its path to profitability.

Singular Health Group reported a $6.38 million loss for FY2025 while securing a pivotal $1.3 million commercial agreement with US-based Provider Network Solutions to deploy its 3DICOM software. The company also completed a major cloud migration of its platform, positioning itself for growth in the US healthcare market.

Cambium Bio reported a $3.84 million loss for FY25 but secured critical FDA approvals and ethics clearances to initiate Phase 3 trials of Elate Ocular®, supported by a $2.12 million capital raise.

Paradigm Biopharmaceuticals marked FY25 with the launch of its global Phase 3 trial for its osteoarthritis drug iPPS, backed by strong FDA protocol approval and a $41 million funding facility. The company also broadened its pipeline with the acquisition of Pentacoxib™, targeting early-stage OA.