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Breakthrough Therapy
Biotech
Denali rare disease drug clears safety study, reduces biomarkers
Denali's drug met its primary safety endpoints and reduced key biomarkers of Hunter syndrome in a phase 1/2 trial, the biotech announced.
Darren Incorvaia
Feb 6, 2025 12:05pm
Concert persuades FDA to keep alopecia therapy breakthrough tag
Feb 15, 2023 10:00am
Sanofi's Hemlibra rival gets FDA breakthrough tag
Jun 1, 2022 10:51am
Blackrock Neurotech’s mind-reading tech named FDA breakthrough
Nov 18, 2021 10:05am
Gilead taps brakes on $4.9B bet after rival's failure
Oct 29, 2021 7:30am
Novocure nabs breakthrough label for liver tumor-treating fields
Sep 10, 2021 9:47am
