FDA Grants Orphan Drug Designation to March Biosciences for T-Cell Lymphoma
By Daniella Parra March Biosciences was granted an orphan drug designation from the FDA to MB-105, its CD5-targeted CAR-T ...
Targeted Oncology3d
FDA Grants Orphan Drug Designation to MB-105 for R/R T-Cell Lymphoma
MB-105, a first-in-class CD5-targeted CAR T-cell therapy, received FDA orphan drug designation for relapsed/refractory T-cell ...
PharmaTimes10d
Zydus announces USFDA Orphan Drug Designation for Usnoflast in ALS treatment
Zydus has announced that the USFDA has granted Orphan Drug Designation (ODD) to Usnoflast, a novel oral NLRP3 inhibitor, for ...
Zydus receives USFDA Orphan Drug Designation for Usnoflast to treat ALS
Zydus Lifesciences announced that the USFDA granted Orphan Drug Designation to Usnoflast, a novel oral NLRP3 inhibitor, for ...
March Biosciences Receives FDA Orphan Drug Designation for MB-105, a First-in-Class CD5 CAR-T Cell Therapy, for T-Cell Lymphoma
Company prepares to advance to Phase 2 clinical trial in early 2025 HOUSTON, Jan. 28, 2025 (GLOBE NEWSWIRE) -- (March Bio), an emerging clinical stage biotechnology company committed to combating ...
money.rediff10d
Zydus Usnoflast Gets Orphan Drug Designation for ALS Treatment
Zydus Lifesciences's Usnoflast receives Orphan Drug Designation from the USFDA for the treatment of Amyotrophic Lateral ...
SEED receives FDA Rare Pediatric Disease, Orphan Drug designations for ST-01156
SEED Therapeutics announced that the U.S. Food and Drug Administration has granted Rare Pediatric Disease and Orphan Drug designations to ...
Zai Lab Gets FDA Orphan Drug Designation For ZL-1310 To Treat Small Cell Lung Cancer
Zai Lab Limited (ZLAB) announced that the U.S. Food and Drug Administration has granted Orphan Drug Designation or ODD to ZL-1310, a ...
Business Wire10d
Zai Lab Receives Orphan Drug Designation from the U.S. FDA for ZL-1310 (DLL3 ADC) for the Treatment of Small Cell Lung Cancer (SCLC)
has granted Orphan Drug Designation (ODD) to ZL-1310, a potential highly active first-in-class DLL3 antibody-drug conjugate (ADC), for the treatment of small cell lung cancer (SCLC).
Pharmabiz2d
March Biosciences receives US FDA orphan drug designation for MB-105 to treat relapsed/refractory CD5-positive T-cell lymphoma
Biosciences receives US FDA orphan drug designation for MB-105 to treat relapsed/refractory CD5-positive T-cell lymphoma: Houston Thursday, January 30, 2025, 17:00 Hrs [IST] ...
Business Wire12d
KalVista Announces Orphan Drug Designation and NDA Submission for Sebetralstat in Japan for Hereditary Angioedema
“The Orphan Drug Designation not only acknowledges the critical need for new, effective treatments for HAE in Japan but underscores the potential of sebetralstat to provide meaningful relief for ...