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CHMP Adopted Positive Opinion for ELZONRIS (tagraxofusp), for the Treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) prnasia
November 18, 2020
The Menarini Group, a privately held Italian pharmaceutical and diagnostics company, announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion on the approval of ..
ImmunoGen gets FDA breakthrough therapy status for IMGN632 to treat relapsed or refractory BPDCN pharmaceutical-business-review
October 10, 2020
ImmunoGen has secured breakthrough therapy status from the US Food and Drug Administration (FDA) for its IMGN632 to treat patients with relapsed or refractory blastic plasmacytoid dendritic cell neoplasm (BPDCN).
FDA Approves Elzonris for BPDCN americanpharmaceuticalreview
December 27, 2018
The U.S. Food and Drug Administration (FDA) approved Elzonris (tagraxofusp-erzs) infusion for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients, two years of age and older.....
FDA Approves Drugs for Treatment of Two Rare Blood Diseases drugs
December 25, 2018
Two drugs have been approved by the U.S. Food and Drug Administration for the treatment of rare blood diseases, the agency announced Friday....
FDA Approves First Treatment for Rare Blood Disease americanpharmaceuticalreview
December 24, 2018
The U.S. Food and Drug Administration (FDA) approved Elzonris (tagraxofusp-erzs) infusion for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients, two years of age and older.....
FDA puts clinical hold on Cellectis' CAR-T cell therapies biospectrumasia
September 19, 2017
Cellectis said it is working with clinical trial investigators and the FDA to resume the trials with an amended trial protocol that includes a lower dose of UCART123.