In a major new entry in the diabetes market, FDA just approved linagliptin and metformin hydrochloride extended-release tablets (Jentadueto XR, Boehringer Ingelheim and Eli Lilly and Company) to treat type 2 diabetes.
FDA recently approved a new indication for afatinib (Gilotrif, Boehringer Ingelheim) for patients with squamous cell carcinoma of the lung. The once-daily tablets are now indicated for the treatment of patients with the lung cancer, whose disease has progressed after treatment with platinum-based chemotherapy. Here are the top 6 facts to know about Gilotrif.
FDA expanded the use of ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets without ribavirin (Viekira Pak, AbbVie) this week to treat patients with genotype 1b (GT1b) chronic hepatitis C virus (HCV) infection and compensated cirrhosis (Child-Pugh A).
FDA advisory committee recently voted to recommend approval of obeticholic acid (Ocaliva, Intercept Pharmaceuticals, Inc.) for the treatment of primary biliary cholangitis (PBC). If approved, Ocaliva would be the first new treatment for PBC in nearly 20 years.
FDA recently approved venetoclax (Venclexta, AbbVie and Genentech) to treat chronic lymphocytic leukemia (CLL) who have a chromosomal abnormality called 17p deletion and who have been treated with at least 1 prior therapy