Sentences with phrase «new molecular entities»

This is the 40th new molecular entity (or drug that has never been approved before) that the FDA has signed off on in 2015 and the third new drug approved to treat this kind of blood cancer this month.

Clinical trials that involve new molecular entities occur all the time, says R. Alta Charo, a bioethicist at the University of Wisconsin Law School in Madison and a former policy adviser to the US Food and Drug Administration.

«The idea behind this initiative is to find new molecular entities that show great promise, activity and safety profiles, and increase the translational potential of natural products research into leads for new medicines,» says Joshua Pierce, an assistant professor of chemistry and leader of NP2D.

In calendar year 2014, the FDA's Center for Drug Evaluation and Research (CDER) approved 41 novel new drugs as new molecular entities (NMEs) under New Drug Applications (NDAs) or as new therapeutic biologics under Biologics License Applications (BLAs).

With the addition of Allergan, Pfizer will enhance its R&D capabilities in both new molecular entities and product line extensions.

21 Number of completely novel drugs («new molecular entities») approved by the FDA Center for Drug Evaluation and Research in 2008.

Genentech's Research and Early Development pipeline has over 25 new molecular entities in clinical development.