ENDPOINTS NEWS9m
CSL Behring will close Cal­i­for­nia of­fice as part of shrink­ing ex vi­vo work
CSL Behring is closing its Pasadena R&D site, relocating operations to Waltham, Massachusetts, affecting 30 employees. The ...
ENDPOINTS NEWS17m
Neu­ro­gene pa­tient had life-threat­en­ing side ef­fect in Rett syn­drome study
Neurogene reported a patient experienced systemic hyperinflammatory syndrome during their Rett syndrome gene therapy trial. CEO Rachel McMinn confirmed the female patient is in critical condition. The ...
ENDPOINTS NEWS36m
Syn­dax's Re­vu­forj wins FDA ap­proval in ag­gres­sive form of leukemia
Syndax Pharmaceuticals won the first FDA approval last week in a new class of medicines called menin inhibitors. The treatment, Rejuforj, will be available as soon as this month for patients with an ...
ENDPOINTS NEWS50m
FDA of­fers more guid­ance on de­vel­op­ing cell and gene ther­a­pies
The FDA on Monday offered new draft guidance to help drugmakers understand the nuts and bolts of FDA processes for developing and submitting an application for a new cell or gene therapy, from pre-IND ...