Pharmaceutical developer Mesoblast’s Revascor (rexlemestrocel-L) drug for children with hypoplastic left heart syndrome (HLHS) has been granted Regenerative Medicine Advanced Therapy designation by the US Food and Drug Administration (FDA). Earlier this year FDA granted REVASCOR both Rare Pediatric Disease Designation (RPDD) and Orphan-Drug Designation (ODD) for congenital heart disease, acknoeledging that the disrase is…
Biotechnology company InhaleRx has secured $38.5 million in funding to further develop its precision medicines delivered via inhalation. Clendon Biotech Capital has entered into a strategic partnership with the company to provide funding to cover all direct costs associated with the Phase 1 & 2 clinical development of its’ key drug development projects – IRX-211…
FDA accepts Mesoblast’s responses Biotech company Mesoblast has announced that the United States Food and Drug Administration (FDA) has accepted Mesoblast’s Biologics License Application (BLA) resubmission for Ryoncil (remestemcel-L) in the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD). According to a statement, the FDA considers the resubmission to be a complete…
IDT Australia to raise $7 million for mRNA vaccine production Pharmaceutical manufacturer IDT Australia is to raise $7 million a fully underwritten entitlement offer of fully paid ordinary shares to eligible shareholders. The funds raised will be used to fund capital expenditure relating to current and potential future works in the mRNA therapeutics field including…
Cyclopharm’s Technegas radiopharmaceutical imaging system has achieved a streamlined reimbursement approval process in the United States, boosting its prospects in what is the world’s largest market. The Sydney company has received a Coding Determination for Technegas from the Center for Medicare Medicaid Services (CMS), which means users will have a unique identifier which streamlines their…
Imaging company EMVision Medical Devices is preparing for a meeting with the US Food and Drug Administration as it edges closer to seeking approval to market its emu point of care scanner to detect stroke. The company has been developing a system that uses microwaves and AI in a machine small enough to fit in…
