Bio-Pharm News
Incyte (INCY) Gains FDA Nod for Monjuvi in Relapsed or Refractory Follicular Lymphoma (FL)
Incyte (INCY) announced that the U.S. Food and Drug Administration has approved Monjuvi® (tafasitamab-cxix), a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody, for use in...
SENTI-202 by Senti Biosciences ($SNTI) Secures FDA Orphan Drug Designation for Rare Hematologic Malignancies
Senti Biosciences (SNTI) announced that the U.S. Food and Drug Administration has granted Orphan Drug Designation to SENTI-202 for relapsed/refractory hematologic malignancies including AML.
SENTI-202...
Deramiocel Scores FDA Orphan Drug Designation, Boosting Capricor Therapeutics ($CAPR) Pipeline
Capricor Therapeutics (CAPR) announced that the U.S. Food and Drug Administration has granted Orphan Drug Designation to Deramiocel. Deramiocel is the lead cell therapy...
CERo Therapeutics ($CERO) Advances AML Treatment with FDA Orphan Drug Status
CERo Therapeutics Holdings, Inc. (CERO) has received Orphan Drug Designation from the U.S. Food and Drug Administration for its lead drug candidate CER-1236, targeting...
Dyne Therapeutics ($DYN) Advances with FDA Breakthrough Therapy Designation for DYNE-101
Dyne Therapeutics, Inc. (DYN) announced that the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation to DYNE-101 for the treatment of myotonic...