REDWOOD CITY, Calif. – Jasper Therapeutics, Inc., a biotechnology company focused on hematopoietic cell transplant therapies, today announced the initiation of a Phase 1/2 clinical trial to evaluate JSP191, the company’s anti-CD117 monoclonal antibody, as a targeted, non-toxic conditioning agent prior to allogeneic transplant in patients with GATA2-related myelodysplastic syndromes...
treatment News
Red Wood City, Calif. — Jasper Therapeutics, Inc. (NASDAQ: JSPR), a biotechnology company focused on developing novel antibody therapies targeting c-Kit (CD117) to address diseases such as chronic spontaneous urticaria and lower to intermediate risk myelodysplastic syndromes (MDS) as well as novel stem cell transplant conditioning regimes, announced that the...
INDIANAPOLIS, Indiana — Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) has granted approval to Jaypirca (pirtobrutinib, 100 mg & 50 mg tablets) for the treatment of adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a...
DUBLIN – Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review designation and confirmed the acceptance for substantive review of the supplemental New Drug Application (sNDA) seeking approval for Xywav™ (calcium, magnesium, potassium, and sodium oxybates) oral solution in adult...
DUBLIN – Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the U.S. Food and Drug Administration (FDA) approved a revised label for Vyxeos® (daunorubicin and cytarabine) to include a new indication to treat newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in pediatric patients aged one year and older. The approval of Vyxeos for...
DUBLIN – Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the first patient has been enrolled in a global Phase 2b clinical trial evaluating the safety and efficacy of suvecaltamide (also known as JZP385), a highly selective modulator of T-type calcium channels in development for the potential treatment of moderate to severe essential...
DUBLIN – Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced the U.S. Food and Drug Administration (FDA) approval of Rylaze™ (asparaginase erwinia chrysanthemi (recombinant)-rywn) for use as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL) in pediatric and adult patients...
DUBLIN – Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the Company has completed the submission of a Supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval for a Monday/Wednesday/Friday (M/W/F) intramuscular (IM) dosing schedule for Rylaze™ (asparaginase erwinia chrysanthemi (recombinant)-rywn), for use as...
DUBLIN, Ireland — Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the company has completed the rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking accelerated approval for the HER2-targeted bispecific antibody zanidatamab as a treatment for previously-treated, unresectable, locally advanced, or...
DUBLIN, Ireland — Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the conditional marketing authorization of zanidatamab, an investigational dual human epidermal growth factor receptor 2 (HER2)-targeted bispecific antibody, as monotherapy...