Latest Fda Approval News

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.

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.

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.

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.

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.

Echo IQ Limited has secured FDA clearance for its EchoSolv AS technology and appointed a US-based CEO, marking a pivotal shift towards commercialisation in the American healthcare market.

NeuroScientific Biopharmaceuticals has initiated critical IND-enabling studies for its glaucoma drug candidate EmtinB, backed by a solid cash position of A$4.5 million as of December 2024. Preliminary melanin binding results are shaping the path toward first-in-human trials.

Algorae Pharmaceuticals reports robust progress in its drug development pipeline, highlighted by promising preclinical results for cardiovascular and dementia candidates and significant AI platform enhancements.