Lub Peb Hlis 2019, Biogen rub txoj kev loj hlob ntawm cov tshuaj tom qab kev tshuaj xyuas los ntawm pab pawg neeg ywj pheej qhia tias nws tsis zoo li yuav ua haujlwm. Lub tuam txhab tom qab ntawd ua rau cov neeg lag luam poob siab ntau lub hlis tom qab tshaj tawm tias nws yuav nrhiav kev pom zoo rau cov tshuaj tom qab tag nrho.
Yuav tshuaj Biogen puas tau txais kev pom zoo?
Biogen Alzheimer's Drug Wins Historic Approval, tab sis FDA Yuav Tsum Tau Txiav Txim Tshiab. Aducanumab, tus neeg sib tw tus kab mob Alzheimer's Biogen tau koom tes nrog Eisai, hnub no tau txais kev pom zoo nrawm los ntawm FDA-uas hinged nws cov ntawv tso cai ntawm cov tshuaj ntawm kev sim tshuaj tshiab.
Puas yog Biogen FDA pom zoo?
US Food and Drug Administration (FDA) tau pom zoo Biogen's monoclonal antibody aducanumab (Aduhelm) rau Lub Rau Hli 7 rau theem pib Alzheimer's kab mob- thawj txoj kev kho tshiab tau pom zoo rau cov kab mob neurogenerative hauv ze li ob xyoo lawm.
Yuav Aducanumab puas tau pom zoo?
Hnub no, US Food and Drug Administration tau pom zoo Aduhelm (aducanumab) rau kev kho mob Alzheimer's, tus kab mob debilitating cuam tshuam rau 6.2 lab tus neeg Asmeskas.
FDA puas tso cai rau Biogen Alzheimer's tshuaj?
US Food and Drug Administration tau pom zoo aducanumab, monoclonal antibody mus los ntawm hom npe Aduhelm, los kho Alzheimer's kab mob hauv cov neeg mob thaum ntxov. Daim ntawv tshaj tawm hnub no (Lub Rau Hli 7) yog thawj zaug hauv 17 xyoo uas FDA tau pom zoo tshuaj los kho tus mob. Kab mob neurodegenerative.