美國食品藥品監(jiān)督管理局（FDA）于2013年度共批準(zhǔn)27個(gè)新藥，其中小分子藥物25個(gè)，生物制品2個(gè)，涉及抗腫瘤、代謝和內(nèi)分泌系統(tǒng)、抗病毒、精神神經(jīng)系統(tǒng)、呼吸系統(tǒng)、伴隨診斷試劑，以及醫(yī)學(xué)影像產(chǎn)品等治療和應(yīng)用領(lǐng)域。與2012年批準(zhǔn)的39個(gè)新藥相比，雖然在產(chǎn)品數(shù)量上有所下降，但這些藥物卻具備廣闊的商業(yè)前景。簡要介紹其中的重點(diǎn)品種，并就新藥研發(fā)的現(xiàn)狀與趨勢進(jìn)行分析。

The US Food and Drug Administration (FDA) approved 27 new drugs in 2013. There were 25 small molecules and 2 biologics in 2013. The current focus for drug R & D were on antineoplastic drugs, metabolic and endocrinological therapies, antivirals, neuropsychiatric drugs, chronic pulmonary disease treatments, companion diagnostic reagents, and medical imaging products. Although the number of approvals in 2013 was down from 2012 with 39 approvals, the newcomers were set to achieve powerful earning potential. The profile of some exciting products and the trends of drug R & D were provided.