Latest Us Fda News

Dimerix Limited has announced a US licensing transaction for its Phase 3 asset DMX-200 targeting FSGS, alongside progress updates on its clinical trial. The move underscores the company’s push to address a rare kidney disease with no approved therapies.

TrivarX has launched a pivotal mental health clinical trial in partnership with the US Department of Veterans Affairs, leveraging its innovative ECG-based technology to screen for major depressive episodes. The company also secured $2.25 million in funding, positioning it for regulatory milestones ahead.

PainChek Limited reports strong progress toward FDA De Novo clearance for US market entry, launches its Infant App in Australia, and achieves robust global licence growth with a 30% year-on-year revenue increase.

IDT Australia reports a robust 30% jump in quarterly revenue to $4.1 million, driven by strong contract wins and a $62 million pipeline of open proposals, signaling sustained growth in pharmaceutical manufacturing.

Zelira Therapeutics has received a $1.15 million cash refund from the Australian Government’s R&D Tax Incentive Scheme, bolstering its working capital to advance clinical development and business operations.

Opthea has completed the final patient visit in its pivotal COAST Phase 3 trial evaluating sozinibercept combined with aflibercept for wet AMD, with topline results expected early Q2 2025.

Recce Pharmaceuticals reports strong Phase II results for its RECCE® 327 topical gel, achieving a 93% efficacy rate in treating serious skin infections and setting the stage for accelerated Phase 3 trials.

The a2 Milk Company has reported robust first-half FY25 results, boosting full-year guidance and declaring its inaugural dividend, underscoring confidence in its growth trajectory.

AdAlta has fast-tracked its cellular immunotherapy growth by signing two new term sheets for clinical-stage CAR-T products from Asia, pivoting to focus on in-licensing and clinical trials while winding down internal R&D on its antifibrotic drug AD-214.

Paradigm Biopharmaceuticals has launched a Loyalty and Piggyback Options program aimed at rewarding shareholders and raising up to $111.96 million to support its pivotal Phase III clinical trial.

Echo IQ confirms the material significance of its pre-submission FDA meeting for EchoSolv HF, marking a pivotal step toward US market entry and commercialisation.

Optiscan Imaging Ltd reported a productive December quarter, marked by key product developments, strategic partnerships, and a stronger cash position, setting the stage for growth in medical and veterinary imaging markets.