MPR14h
Tau-Targeting Antisense Therapy for Alzheimer Disease Gets Fast Track Status
BIIB080 is an antisense oligonucleotide therapy designed to target microtubule-associated protein tau mRNA and reduce the production of tau.
Biogen’s Investigational Tau-Targeting Therapy BIIB080 Receives FDA Fast Track Designation for the Treatment of Alzheimer’s Disease
Biogen Inc. (Nasdaq: BIIB) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track ...
PharmExec15h
FDA Grants Fast Track Designation to Biogen’s Novel Alzheimer Disease Drug Candidate
BIIB080 marks the first antisense oligonucleotide targeting tau to enter clinical development for the treatment of Alzheimer ...
Biogen's BIIB080 Gets FDA Fast-Track Designation in Alzheimer's Disease
Biogen on Wednesday said BIIB080 is the first tau-targeting antisense oligonucleotide therapy to enter clinical development for Alzheimer's disease and that it is currently being evaluated in a global ...
Biogen announces U.S. FDA granted Fast Track designation to BIIB080
Biogen (BIIB) announced that the U.S. Food and Drug Administration, FDA, has granted Fast Track designation to BIIB080, an investigational ...
BioSpace2d
Lilly’s RNA Silencer Lowers Key Cardiovascular Biomarker by Almost 94%
BMO Capital Markets analysts said the results potentially position lepodisiran as “one of the most durable assets in ...
Scientists Discover How To Reactivate Cancer’s Dormant “Kill Switch”
The discovery could pave the way for a groundbreaking RNA-based multi-cancer treatment. Alternative RNA splicing functions ...
ALS News Today19h
Silence ALS treats 9 patients’ rare ALS caused by CHCHD10 mutations
The U.S. Food and Drug Administration approved treatment for 11 patients with the rare familial ALS caused by mutations in ...
Managed Healthcare Executive8d
FDA Grants Priority Review BLA for Spinal Muscular Atrophy Drug, Apitegromab
A Prescription Drug User Fee Act (PDUFA) target action date for apitegromab has been set for Sept. 22, 2025.
Biogen’s tau targeting Alzheimer’s disease therapy gets FDA Fast Track status
Biogen (NASDAQ:BIIB) said on Wednesday that the U.S. FDA has granted Fast Track designation to BIIB080, its antisense ...