FDA Approves Krystal Gene Therapy For Rare Wound Disorder
The Food and Drug Administration on Friday approved the first topical gene therapy, clearing a treatment developed by Krystal Biotech for a rare genetic skin…
Carbon
FDA Approves Mesoblast’s First-Of-Its-Kind Cell Therapy
For Australian biotech Mesoblast, it took three go-rounds with the FDA to win approval of Ryoncil, a cell therapy for graft versus host disease.
FDA Approves World’s First CRISPR-Based Medicine For Sickle Cell
The Food and Drug Administration on Friday approved the world’s first medicine based on CRISPR gene-editing technology, a groundbreaking treatment for sickle cell disease that delivers…
FDA Blesses CellTrans’ Lantidra
Much attention has been paid to Vertex’s efforts to develop a stem cell therapy for Type 1 diabetes. But flying under the radar with…
FDA Greenlights BMS, J&J CAR-T Therapies
The approvals, third line for BMS and 2seventy Bio’s Abecma and second line for J&J and Legend Biotech’s Carvykti, represent a new class of…
FDA Signs Off on Adaptimmune’s Tecelra
Patients with a certain type of synovial sarcoma have a new treatment option for the first time in more than a decade as the…
Ferring Receives Approval from U.S. FDA for Adstiladrin
Ferring’s novel adenovirus vector-based gene therapy Adstiladrin® (nadofaragene firadenovec-vncg) is the first gene therapy approved for bladder cancer.
Growth of Value-Based Purchasing For Cell & Gene Therapies
Rx Data Reporting Stops Short of Price Transparency PBMs find a way around CMS requirement meant to prevent hidden rebates
Inflation Impacts Healthcare Costs and Self-Insured Benefit Plans
The impact of inflation on the broader economy will likely lead to rising healthcare claim costs in an already inflated high price market. Carbon…
Medicaid Best Price 101
The lowest price available from the manufacturer during the rebate period to any wholesaler, retailer, provider, health maintenance organization, nonprofit entity, or governmental entity…
