The U.S. Food and Drug Administration has declined to approve Ultragenyx Pharmaceutical's experimental gene therapy to treat ...

States representing about 84% of Medicaid beneficiaries are participating in an initiative that enables the U.S. government ...

While the CRL derails a near-term clearance, one analyst described the rejection as more of “a speed bump to approval, rather ...

The Centers for Medicare and Medicaid Services (CMS) has selected 35 participants for its new, voluntary Cell and Gene ...

- ZEVASKYN is the only FDA-approved therapy to treat RDEB wounds with a single application - ...

Sanofi has been granted a speedy review from the FDA for a gene therapy for geographic atrophy (GA), a complication of age-related macular degeneration (AMD), as it prepares to test it in a clinical ...

This study marks the first time gene therapy has shown consistent success in both children and adults with OTOF-related ...

Nanoscope Therapeutics submitted the first modules of a biologics license application for MCO-010, an investigational gene ...

The OUTREACH Study – Demonstrating that CAR-T therapies can be effectively administered in community cancer settings: In the ...

Paris: Sanofi has received fast track designation from the US Food and Drug Administration (FDA) for SAR446597, a one-time ...

This is the first time such results have been achieved in both children and adult patients born with a specific type of ...

Scientists from the Centenary Institute and the University of Sydney have made a landmark discovery that could lead to safer ...