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 ...
PharmaTimes11d
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 ...
Pharmabiz4d
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] ...
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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 ...
Targeted Oncology4d
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 ...
Business Wire11d
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 ...
devdiscourse11d
Zydus Strides Forward with Orphan Drug for ALS
Zydus Lifesciences announced that Usnoflast, a treatment for amyotrophic lateral sclerosis (ALS), has received Orphan Drug Designation from the US FDA. This designation supports the development of ...
Morningstar11d
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)
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) Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced the ...
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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 ...