Last year was poor in terms of biotech drug approvals; the Food and Drug Administration (FDA) approved only 6 biologics, down from 16 in 2003 and well below the average of about 12 since 1999. Development times for biologics are also increasing (up to 7 years for 2000–2004), comparable with those for small molecules. On the bright side, standard review time at the FDA has been trimmed down to 2 years over the same period. Drugs tackling cancer, infectious disease and the central nervous system predominate in the biotech pipeline
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01 July 2005
Nat. Biotechnol. 23, 644 (2005) On the x-axis of the graph “Approval times for priority and standard BLAs,” the years should have ranged, from left to right, from 1995 to 2004. In addition, the colors of all but the last number are incorrect. The upper numbers should have been brown and the lower blue.
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Lawrence, S. Biotech hits regulatory doldrums. Nat Biotechnol 23, 644 (2005). https://doi.org/10.1038/nbt0605-644
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DOI: https://doi.org/10.1038/nbt0605-644
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