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breakthrough designation
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
Karius snares FDA breakthrough tag for infectious disease test
May 16, 2024 7:55am
Roche, Lilly blood test for Alzheimer's expedited at FDA
Apr 11, 2024 11:06am
Anumana's Pfizer-backed AI algorithm nabs FDA breakthrough tag
Jun 22, 2023 10:29am
Brain implant maker Paradromics nabs $33M, FDA breakthrough tag
May 19, 2023 1:39pm
Reach Neuro's spinal cord stimulator nets FDA breakthrough tag
Apr 12, 2023 3:20pm
