The European Commission has approved Astellas' oral once-daily therapy Xospata (gilteritinib) as a monotherapy for the treatment of adult patients with relapsed or refractory (resistant to treatment) acute myeloid leukemia with a FLT3 mutation. Gilteritinib has the potential to improve treatment outcomes for AML patients with two forms of the most common mutation—FLT3 internal tandem duplication and FLT3 tyrosine kinase domain mutation.
FDA granted Shreis Scalene Sciences Breakthrough Device Designation for the Cytotron, a CE-marked, whole-body therapeutic medical device. The Center for Devices and Radiological Health granted the designation. The company’s designation request stated that “The Cytotron is intended to be used to cause degeneration of uncontrolled growth of tissues. It is indicated for treating protein-linked, abnormally […]
Ziopharm Oncology Inc. and MD Anderson Cancer Center established a research and development agreement relating to Ziopharm’s Sleeping Beauty immunotherapy program to use non-viral gene transfer to stably express and clinically evaluate neoantigen-specific T-cell receptors in T cells. “This new agreement is a launch point to expand our TCR library and execute two new clinical […]
FDA approves indication for Zejula in advanced ovarian, fallopian tube, or primary peritoneal cancer
FDA approved GlaxoSmithKline's Zejula (niraparib) for treatment of advanced ovarian, fallopian tube, or primary peritoneal cancer.
FDA approved myChoice CDx for use as a companion diagnostic to identify women with advanced ovarian cancer who are candidates for Zejula (niraparib) in the late-line treatment setting.
The European Commission approved a dosing schedule for Bristol-Myers Squibb's Opdivo (nivolumab) as adjuvant treatment in adult melanoma patients with lymph node involvement or metastatic disease who have undergone complete resection.
FDA has approved Fast Track designation for bemcentinib for treatment of elderly patients with acute myeloid leukaemia (AML) whose disease has relapsed.
In light of new FDA labeling recommendations for saline and silicone gel-filled breast implants, FDA officials Amy Abernethy and Jeffrey E. Shuren issued a statement outlining the agency's recommendations for manufacturers.
For the first time, FDA has authorized the marketing of products through the modified risk tobacco product pathway. The authorizations are for eight Swedish Match USA, Inc. snus smokeless tobacco products sold under the “General” brand name.
The Dutch company Xenikos B.V. said FDA has granted Fast Track designation to T-Guard, Xenikos's product designed to treat steroid-refractory acute graft-versus-host disease in patients following allogeneic stem cell transplantation.
