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.
Flatiron Health announced the availability of its clinical decision support and pathways application, Flatiron Assist, in the App Orchard.
FDA has published a guidance for industry on an optional streamlined submission process for determining whether investigational in vitro diagnostic in clinical trials for an oncology therapeutic is considered significant risk, nonsignificant risk, or exempt from investigational device exemption requirements.
The National Medical Products Administration in China approved Merck's Keytruda as monotherapy for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer whose tumors express PD-L1, with no EGFR or ALK genomic tumor aberrations.