Jazz Pharmacueticals

Jazz Pharmacueticals
Share

Jazz Pharmacueticals

 •  May 31

Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing with Priority Review its recently submitted New Drug Application (NDA) for VYXEOS™ (cytarabine and daunorubicin) liposome injection, an investigational treatment for acute myeloid leukemia (AML), a rapidly progressing...

Jazz Pharmacueticals

 •  April 3

Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced the completion on March 31, 2017 of a rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the approval of Vyxeos™ (cytarabine and daunorubicin) liposome for injection, an investigational treatment for acute myeloid leukemia (AML), a rapidly...

Jazz Pharmacueticals

 •  March 30

Jazz to receive an upfront payment and subsequent milestone-based payments
Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that it has entered into license agreements with Nippon Shinyaku, Co., Ltd. for Defitelio® (defibrotide sodium) and Vyxeos™ (cytarabine and daunorubicin liposome injection), or CPX-351, in Japan.
Under the terms of the...

Jazz Pharmacueticals

 •  October 3, 2016

Jazz Pharmaceuticals plc (Nasdaq; JAZZ) today announced the initiation of a rolling submission of a New Drug Application (NDA) to the United States (U.S.) Food and Drug Administration (FDA) on September 30, 2016, seeking marketing approval of Vyxeos™ (cytarabine and daunorubicin liposome injection), an investigational agent for the treatment of...

Jazz Pharmacueticals

 •  August 2, 2016

Add-On Payment to Provide Additional Medicare Reimbursement for Defitelio and to Support Patient Access in the Inpatient PPS Hospital Setting
Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the United States (U.S.) Centers for Medicare and Medicaid Services (CMS) has granted a New Technology Add-on Payment (NTAP) for Defitelio®...

Jazz Pharmacueticals

 •  July 28, 2016

Jazz Pharmaceuticals plc (Nasdaq: JAZZ) and Pfenex Inc. (NYSE MKT: PFNX) today announced an agreement under which Pfenex granted Jazz Pharmaceuticals worldwide rights to develop and commercialize multiple early stage hematology product candidates. The agreement also includes an option for Jazz Pharmaceuticals to negotiate a license for a...

Jazz Pharmacueticals

 •  July 25, 2016

Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that it will report its 2016 second quarter financial results on Tuesday, August 9, 2016, after the close of the financial markets. Company management will host a live audio webcast immediately following the announcement at 4:30 p.m. EDT/9:30 p.m. IST to discuss second quarter 2016 financial...

Jazz Pharmacueticals

 •  March 30, 2016

First and Only FDA-Approved Therapy for Patients with this Rare, Potentially Fatal Complication
Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the United States (U.S.) Food and Drug Administration (FDA) granted marketing approval for Defitelio® (defibrotide sodium) for the treatment of adult and pediatric patients with hepatic VOD,...

Jazz Pharmacueticals

 •  March 30, 2016

Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the company will host a webcast on Thursday, March 31, 2016 at 4:30 p.m. EDT/9:30 p.m. IST to provide investors with an update on Defitelio, which was approved by the U.S. Food and Drug Administration on March 30, 2016 for the treatment of adult and pediatric patients with hepatic...

Jazz Pharmacueticals

 •  February 18, 2016

Jazz-Sponsored Oral Presentations Include: Results from a Pivotal Phase 3 Trial for the Treatment of VOD with MOD, Sub-Analysis Data from a Phase 3 Pediatric Trial for VOD Prophylaxis, and an Exploratory Post-Hoc Analysis from an Expanded Access Treatment of VOD / SOS Study to Evaluate Timing of Treatment Initiation
10 Jazz-Sponsored Posters Also to Be Presented Jazz-Sponsored Oral Presentations Include: Results from a Pivotal Phase 3 Trial for the Treatment of VOD with MOD, Sub-Analysis Data from a Phase 3 Pediatric Trial for VOD Prophylaxis, and an Exploratory Post-Hoc Analysis from an Expanded Access Treatment of VOD / SOS Study to Evaluate Timing of Treatment Initiation
10 Jazz-Sponsored Posters Also...