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 ...
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 ...
Pfizer (NYSE:PFE) and Danish drugmaker Genmab (GMAB) announced Monday that the U.S. FDA accepted a supplemental Biologics License Application granting full approval for their cervical cancer ...
But the head of the FDA’s CBER office didn’t tip where the agency stands on potentially broadening use of Sarepta’s Duchenne gene therapy Elevidys.
The new guidance explains that once a sponsor receives an abbreviated new drug application (ANDA), new drug application (NDA) ...
Kendric Cromer is the first patient in the U.S. to undergo a newly approved gene therapy for sickle cell disease.
Amgen on Tuesday secured the FDA’s green light for the first interchangeable biosimilar to AstraZeneca’s Soliris to treat two ...
Philadelphia is home to nearly 10 percent of the world’s cell and gene therapy companies, employing about 7,000 people, ...
The global cell and gene therapy market is experiencing significant growth, driven by technological advancements, increasing ...
As scientists celebrate gene therapy's ability to enable hearing, deaf people are feeling a familiar dread: Are we endangered ...
Smoking is a major driver for bladder cancer. Now, a new treatment has come to Philadelphia to help more patients maintain ...
Eladocagene exuparvovec is a one-time, recombinant adeno-associated virus serotype 2-based gene replacement therapy.