Latest Fda News

Visioneering Technologies reported a mixed Q4 FY'24 with a slight revenue decline but stronger cash flow and expanding global footprint, underpinned by promising clinical trial data.

Mesoblast Limited is set to launch Ryoncil®, the first FDA-approved MSC therapy for pediatric steroid-refractory acute graft-versus-host disease, backed by a recent $160 million financing that strengthens its commercial and clinical development efforts.

Mesoblast has secured FDA approval for Ryoncil®, the first mesenchymal stromal cell therapy for steroid-refractory acute graft versus host disease in children, while raising A$260 million to accelerate clinical trials and commercial rollout.

Botanix Pharmaceuticals has initiated the commercial rollout of Sofdra, its FDA-approved treatment for primary axillary hyperhidrosis, with first prescriptions dispensed and a fully trained sales force deployed. The company anticipates meaningful revenue growth starting in the first quarter of 2025, backed by strong payer contracts and a robust cash position.

Genetic Signatures reported a robust 190% increase in quarterly sales to $3.8 million, driven by strong respiratory testing demand in Australia and strategic UK deployments. Despite longer US sales cycles, the company maintains a solid $40.8 million cash position and advances R&D on its 3base® platform.

INOVIQ's December quarterly update reveals significant progress in its cancer diagnostic and therapeutic programs, including a highly accurate ovarian cancer screening test and promising breast cancer therapeutics, supported by growing EXO-NET customer adoption and a solid cash position.

Lumos Diagnostics reported a robust Q2 FY25 with a 71% revenue increase to US$2.9 million, driven by strong product and service sales, alongside a strategic US$3 million BARDA partnership to advance its FebriDx test.

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.

Control Bionics has delivered its strongest US sales quarter in years, nearing US$1 million in revenue, while broadening its market footprint with new commercial agreements and cost optimizations.

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.

ImpediMed Limited has reported record quarterly revenue and cash receipts for Q2 FY25, alongside significant growth in reimbursement coverage and a robust sales pipeline, signaling strong momentum in its digital health platform business.

TrivarX has solidified its regulatory strategy for the pivotal MEB-001 trial with the FDA and unveiled a new algorithm that expands its mental health screening reach beyond sleep clinics.