Brazil Suspends Use of ELEVIDYS (delandistrogene moxeparvovec)
The Brazilian Health Regulatory Agency (Anvisa) announced that it has temporarily suspended the marketing, distribution, manufacturing, import, advertising, and use of the gene therapy...
FDA Designates Avidity Biosciences’ Delpacibart Zotadirsen (del-zota) as a Breakthrough Therapy for the Treatment of DMD in Individuals with Mutations That Allow for Exon...
Avidity Biosciences today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to delpacibart zotadirsen (del-zota) for the treatment...
The FDA Designates PBGENE-DMD as an Orphan Drug by Precision BioSciences to Treat Duchenne Muscular Dystrophy
Precision BioSciences, a clinical stage gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for diseases with...
Sarepta Therapeutics Announces Pause of ELEVIDYS Shipments in the USA
Today, Sarepta Therapeutics notified the U.S. Food and Drug Administration (FDA) of its decision to voluntarily and temporarily pause all shipments of ELEVIDYS (delandistrogene...
Sarepta to Lay Off About 500 Employees After Duchenne Gene Therapy Setbacks
Sarepta stated that company intends to halt development on a number of medicinal products and lay off about 36% of its employees. By 2026,...