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 ...
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 2025HOUSTON, Jan. 28, 2025 (GLOBE NEWSWIRE) -- March Biosciences (March Bio), an ...
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 ...
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] ...
News Medical9d
What is an Orphan Drug? A Guide to Rare Disease Therapies
Orphan drugs offer critical treatment options for rare diseases, improving quality of life for underserved patients and ...
PharmaTimes9d
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 ...
KalVista Announces Orphan Drug Designation and NDA Submission for Sebetralstat in Japan for Hereditary Angioedema
KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has ...
ophthalmologytimes9d
FDA grants fast track designation to N-acetylcysteine amide tablets from Nacuity Pharmaceuticals
The NPI-001 (N-acetylcysteine amide) tablets are a proprietary investigational therapy for the treatment of patients with ...
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).
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 ...