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The US Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER) approved 15 new molecular entities and 6 new biologics in 2010. The total of 21 new products falls...
1 lut 2011 · First things first. Several new medications are the first of their kind or serve a previously unmet need. Tocilizumab, or Actemra, was licensed in January and became the first new molecular entity or biologic approved in 2010.
29 gru 2010 · We examine drug development performance metrics for new product approvals during 2000–2009 and compare them with those of the prior two decades. The results indicate that, whereas total approvals are currently at a 25-year low, the percentage of priority products is nearly 50% of the total—a 30-year high.
Drug approvals included new molecular entities, biologic license applications, as well as reformulations, combinations and new indication approvals.
30 maj 2019 · Article PDF Available. The impact of external innovation on new drug approvals: A retrospective analysis. May 2019. International Journal of Pharmaceutics 563:273-281. DOI:...
The mean annual number of new drug approvals, including biologics, was 34 from 1990-1999, 25 from 2000-2009, and 41 from 2010-2018. New biologic product approvals increased from a median of 2.5 from 1990-1999, to 5 from 2000-2013, to 12 from 2014-2018.
1 lip 2011 · Request full-text PDF. To read the full-text of this research, you can request a copy directly from the author.
