Latest Us Fda News

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.

PainChek Ltd reports robust growth with 100,000 contracted licences globally and positive FDA clearance progress, alongside a promising launch of its Infant App targeting a vast new market.

BlinkLab has launched its pivotal FDA registrational study for its AI-driven autism diagnostic app, BlinkLab Dx 1, following positive FDA feedback and promising preliminary results.

Island Pharmaceuticals reports promising safety and anti-dengue activity in its Phase 2a trial of ISLA-101 and has commenced the Phase 2b therapeutic arm, backed by a fresh A$3.5 million capital raise.

Neurizon Therapeutics reports encouraging 8-month interim results for its ALS drug NUZ-001, secures Orphan Medicinal Product Designation in Europe, and raises $885,000 through a share placement, maintaining a robust $14 million cash position.

IDT Australia reports a near doubling of quarterly revenue to $5.3 million, driven by explosive growth in its Advanced Therapies segment, with first-half revenue expected to jump 82%.

InhaleRx has corrected its quarterly report and revealed a $38.5 million funding deal to fast-track clinical trials for its inhaled therapies targeting breakthrough cancer pain and panic disorder, aiming for FDA approval.