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 Oncology2d
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 ...
BioSpace5h
Drug Pricing and the Uncertain Future of the IRA Under Trump
While the former Biden administration showcased the Inflation Reduction Act as a key victory in the fight over high drug ...
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 ...
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 ...
Pharmabiz1d
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] ...
pharmaphorum1d
The status of orphan drugs in China
As we near the end of our “emerging markets” focus month, Chia Wen Lee and Betty Su share their thoughts on the status of orphan drugs in China, one of the largest emerging markets in the world.
Stockhead on MSN1d
Health Check: Alterity angles for fast-track FDA approval after positive trial results tackling Parkinson’s-like disorder
Alterity plans to seek US FDA fast-track approval after posting positive phase II results for multiple system atrophy ...
AB2 Bio signs U.S. option and licensing agreement with Nippon Shinyaku for Tadekinig alfa for an ultra-rare autoimmune disease
Agreement grants Nippon Shinyaku an option to acquire exclusive U.S. rights to commercialize AB2 Bio’s Tadekinig alfa to treat Primary Monogenic ...
JD Supra3d
Key regulatory changes impacting the healthcare industry in the EU and Germany in 2025
The regulatory frameworks in the life sciences and healthcare sector keep evolving rapidly and dynamically. Several important legislative reforms ...