FDA recently approved rucaparib (Rubraca, Clovis Oncology) tablets to treat patients with deleterious BRCA mutation (germline and/or somatic)-associated advanced ovarian cancer, who have been treated with 2 or more chemotherapies.
A new combination drug for type 2 diabetes will available in the US in the coming months.
FDA issued two important drug warnings this week: one linking certain diabetes medications to bladder cancer and another about the use of general anesthetic and sedation drugs during pregnancy.
FDA recently approved bevacizumab (Avastin, Genentech) for patients with platinum-sensitive recurrent epithelial ovarian (psOC), fallopian tube or primary peritoneal cancer.
FDA’s approval of a new indication for empagliflozin (Jardiance, Eli Lilly and Boehringer Ingelheim) could net the pharmaceutical manufacturers more than $1 billion.
Two new diabetes drugs, both long-acting injectable insulin products, were simultaneously approved by FDA.
FDA granted Breakthrough Therapy Designation to brentuximab vedotin (Adcetris, Seattle Genetics) to treat patients with the most common subtypes of lymphoma.
After Gilead received FDA approval for a new drug for chronic hepatitis B virus (HBV), it said low-cost, generic versions would also soon be available. That is good news for Gilead, which has been targeted by Congressional representatives for the high cost of Sovaldi and Harvoni hepatitis C treatments.