The therapy has been approved in the USA since 2024, and it'll soon be available down under as well, potentially reimbursed by Australia's pharma subsidy program.
As MEDIPOST ventures abroad, Charles River will provide GMP-compliant biologics and cell therapy testing services to help advance the pipeline into new markets.
The partnership combines Dark Horse's regulatory and development consulting with KunTuo's on-the-ground clinical trial execution to help companies launch studies faster and generate data to support regulatory submissions.
The trial demonstrated that Cartistem can both relieve symptoms and regenerate cartilage, and the company is advancing manufacturing readiness for its first overseas commercialization move.
Regeneron said it will reduce Medicaid and future U.S. drug prices in line with other developed countries, enable direct discounted purchases of Praluent through TrumpRx.gov, and continue investing in domestic R&D and...
The recommendation is backed by Phase III data showing that Novartis’ one-time gene therapy improved motor function in people aged two and older with SMA and could lessen reliance on ongoing chronic...
Orthocell has gained approval for its Remplir nerve repair device across U.S. Department of Defence and Veterans Affairs hospital networks, expanding access to more than 220 military and veteran care facilities as...
Gallant said its pilot study found that intravenous stem cell therapy significantly improved pain and quality of life in cats with osteoarthritis versus placebo, supporting a faster regulatory route as the company...
A proposed class action alleges QC Kinetix and related defendants failed to disclose that certain regenerative pain treatments were not FDA-approved and used misleading financing offers to sell them.
Miracell has received FDA 510(k) clearance for its SMART M-CELL blood and bone marrow concentration systems and kits, an automated platform the company says uses patented separation technology to preserve cell viability...
