December 16, 2015 – This post is somewhat delayed; however, it may still be of  interest for some readers of thasso post and therefore, the information is provided here uncommented, as it was issued by both the FDA and the EMA …

Idarucizumab (Praxbind): Antidote for Dabigatran (Pradaxa) approved by FDA and recommended for approval by EMA Read more »

December 12, 2011 – This is from a press release from December 07, 2011: FDA is evaluating post-marketing reports of serious bleeding events in patients taking Pradaxa (dabigatran etexilate mesylate). Bleeding that may lead to serious or even fatal outcomes …

Dabigatran [Pradaxa]: Drug Safety Communication – Safety Review of Post-Market Reports of Serious Bleeding Events Read more »