The Milton and Carroll Petrie Department of Urology at the Icahn School of Medicine at Mount Sinai received a $1 million grant from The Arthur M. Blank Family Foundation.
A Senate committee Dec. 3 cleared the path for Stephen M. Hahn to become the next FDA commissioner, though some Democratic and Republican senators voiced concerns that he wouldn't take aggressive action to ban flavored e-cigarettes in this role.
The progress in cancer exceeds that of any other therapeutic area right now—at least as far as FDA is concerned, NCI Director Ned Sharpless said at a Dec. 3 joint meeting of the Board of Scientific Advisors and the National Cancer Advisory Board.
After an examination of the causes of an avalanche of grant applications directed at NCI, institute officials found that new applications largely come from principal investigators who are switching their research focus to cancer. No other NIH institute or center faces such pressure.
FDA takes second action under international collaboration, approving treatment option for CLL or SLL
As part of Project Orbis, a collaboration with the Australian Therapeutic Goods Administration and Health Canada, FDA granted supplemental approval to Calquence (acalabrutinib) for the treatment of adults with chronic lymphocytic leukemia or small lymphocytic lymphoma. This new approved indication for Calquence provides a new treatment option for patients with CLL or SLL as an initial or subsequent therapy.
FDA approved Q BioMed Inc.'s contract manufacturer IsoTherapeutics Group LLC Nov. 20, which it cleared to manufacture the company's FDA-approved non-opioid cancer bone pain drug Strontium-89 Chloride USP.
FDA approved Adakveo (crizanlizumab-tmca) to reduce the frequency of vaso-occlusive crises in adults and pediatric patients 16 and older with sickle cell disease.
FDA approved Alnylam Pharmaceuticals Inc.'s Givlaari (givosiran) for adults with acute hepatic porphyria.
The European Commission has approved Merck's Keytruda as monotherapy or in combination with platinum and 5-fluorouracil chemotherapy, for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma whose tumors express PD-L1 (combined positive score [CPS] ≥1). The drug was approved Nov. 20.
The European Commission has has granted marketing authorization for Darzalex (daratumumab) in combination with lenalidomide and dexamethasone (Rd) as treatment for adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
