FDA granted premarket approval to Thermo Fisher Scientific for the first next-generation sequencing-based test that simultaneously screens tumor samples for biomarkers associated with three FDA-approved therapies for non-small cell lung cancer.
FDA rejected Pfizer's Biologics License Application for its proposed epoetin alfa biosimilar to Amgen's Epogen, citing significant violations of good manufacturing practice regulations for finished pharmaceuticals at the company's drug manufacturing facility, Hospira Inc., in McPherson, KS.
FDA approved betrixaban (BEVYXXA) for the prophylaxis of venous thromboembolism in adult patients hospitalized for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE.
Amgen said FDA has accepted the Xgeva (denosumab) supplemental Biologics License Application that seeks to expand the currently approved indication for the prevention of fractures and other skeletal-related events in patients with bone metastases from solid tumors to include patients with multiple myeloma.
CancerCare has established the CancerCare Patient Values Initiative, a multi-pronged effort with an aim to reframe the national healthcare policy dialogue to include issues important to patients and their families.
Rectal cancer programs interested in earning accreditation from the new National Accreditation Program for Rectal Cancer may apply for participation in the program. The goal of the NAPRC is to ensure rectal cancer patients receive appropriate care using a multidisciplinary approach.
If the June 22 Senate appropriations hearing is an indication, President Donald Trump will encounter considerable difficulty in accomplishing his stated goal of cutting the NIH budget by 21 percent in fiscal 2018.
NCI Acting Director Douglas Lowy will continue to serve as deputy director of the institute after Norman "Ned" Sharpless, director of the UNC Lineberger Comprehensive Cancer Center and the Wellcome Distinguished Professor in Cancer Research, is sworn in as the next NCI director.
Less than a year after the Cancer Moonshot's NCI Blue Ribbon Panel identified 10 opportunities in cancer research, NCI has published 24 funding opportunity announcements to conduct research based on the panel's scientific recommendations.
FDA approved the immunotherapy Darzalex (daratumumab) in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.
