Pfizer's first FDA-approved gene therapy is one of the most expensive medications in the U.S. On April 26, Beqvez (fidanacogene elaparvovec-dzkt) won approval to treat some adults with moderate-to ...
Pfizer's huge facility in Sanford produces its first FDA-approved gene therapy, which runs $3.5 million a dose. The U.S. Food and Drug Administration has approved a gene therapy developed by ...
The FDA has bestowed a green light to a companion diagnostic for Pfizer’s recently approved hemophilia B gene therapy—because, at a cost of $3.5 million per dose, you want to make sure it will ...
Assay expands company's leadership in precision medicine and cell and gene therapy BURLINGTON, N.C., April 29, 2024 /PRNewswire/ -- Labcorp (NYSE: LH), a global leader of innovative and ...
The US Food and Drug Administration (FDA) has approved Labcorp’s nAbCyte Anti-AAVRh74var HB-FE assay as a companion diagnostic to Pfizer’s Beqvez (fidanacogene elaparvovec-dzkt). The assay ...
If a patient tests positive for antibodies to AAVRh74var, Beqvez should not be administered. Beqvez is indicated for the treatment of adults with moderate to severe hemophilia B who currently use ...
Welcome to 2024's regulatory tracker for Fierce Pharma. On this page, we're recording the regulatory progress of in-market products, including expansions into key geographies and new indications.
It’s estimated that as many as 20 million Americans may suffer from peripheral artery disease, a condition where a person’s arms or legs don’t receive enough blood to keep up with what they ...
BURLINGTON, N.C., April 29, 2024 /PRNewswire/ -- Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, today announced the U.S. Food and Drug Administration ...
Labcorp, a global leader of innovative and comprehensive laboratory services, announced the US Food and Drug Administration (FDA) has approved its nAbCyte Anti-AAVRh74var HB-FE Assay, a companion ...