Jazz Pharmaceuticals plc announced that data from the phase III pivotal study of defibrotide were published online in BLOOD, the...
Jazz Pharmaceuticals plc announced that FDA has accepted for filing with Priority Review its recently submitted New Drug Application (NDA)...
Jazz Pharmaceuticals plc announced the initiation of a rolling submission of a New Drug Application (NDA) to the United States...
The FDA has approved Defitelio (defibrotide sodium), from Jazz Pharmaceuticals, to treat adults and children who develop hepatic veno-occlusive disease...
Gentium S.p.A. had presented an oral explanation at the EMA Committee for Medicinal Products for Human Use ("CHMP") as part...
On 25 July 2013, the CHMP, following a re-examination procedure, adopted a final positive opinion, recommending to grant a marketing...
Defitelio is indicated for the treatment of severe hepatic veno-occlusive disease (VOD) also known as sinusoidal obstruction syndrome (SOS) in haematopoietic stem-cell transplantation (HSCT) therapy. It is indicated in adults and in adolescents, children and infants over 1 month of age.
On 21 March 2013, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal...
Jazz Pharmaceuticals plc has announced that the company has signed a definitive agreement with Sigma-Tau Pharmaceuticals, Inc. under which a...
This review focuses on the current and potential future treatment of NASH and the clinical practice in fatty liver transplantation, highlights its limitations and optimal allocation, and summarizes the advances of experimental...