Gentium S.p.A.

Gentium SRL, a Jazz Pharmaceuticals company, will be writing to health care professionals in the EU advising them that its orphan drug Defitelio (defibrotide) should not be used to prevent liver ve

While the FDA insisted there was absolutely no connection to its June 2 release of its revised expanded access guidances, which include the finalization of a streamlined process for doctors to request

FDA continues to make 2016 the year of the complete response letter, with three more CRLs announced in the past week. Complete response letters had been declining for years, especially for new molecul

It was old home week at Keeping Track, featuring the return of two previously withdrawn new drug applications and, in what is now a regular occurrence, two immuno-oncology approvals. Even the new fili