FDA moves on breakthrough therapies
Two cystic fibrosis drugs have gained the first breakthrough therapy designation from the US Food and Drug Administration (FDA). In January, the agency announced that Vertexs Kalydeco (ivacaftor) alone and in combination with the experimental compound VX-809 would be the first to benefit from an exp...
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| Veröffentlicht in: | Nature biotechnology 2013-05, Vol.31 (5), p.374-374 |
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| container_title | Nature biotechnology |
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| creator | Fox, Jeffrey L |
| description | Two cystic fibrosis drugs have gained the first breakthrough therapy designation from the US Food and Drug Administration (FDA). In January, the agency announced that Vertexs Kalydeco (ivacaftor) alone and in combination with the experimental compound VX-809 would be the first to benefit from an expedited review process designed for potentially lifesaving drugs. In March, FDA added two oncology drugs to this pathway: the experimental lymphoma drug ibrutinib from Pharmacyclics of Sunnyvale, California, and the Novartis candidate drug LDK378 for treating lung cancer. |
| doi_str_mv | 10.1038/nbt0513-374a |
| format | Article |
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| subjects | 692/308/153 Agriculture Aminophenols - therapeutic use Aminopyridines - therapeutic use Benzodioxoles - therapeutic use Bioinformatics Biomedical and Life Sciences Biomedical Engineering/Biotechnology Biomedicine Biotechnology Cystic fibrosis Drug approval Drug Approval - organization & administration Drug therapy FDA approval Laws, regulations and rules Life Sciences Lung cancer Lymphoma Neoplasms - drug therapy news Quinolones - therapeutic use Terminal Care - trends United States |
| title | FDA moves on breakthrough therapies |
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