FDA Approvals

New diabetes drug enters competitive marketIn 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.
Why new bladder cancer drug is novelFDA recently granted accelerated approval for atezolizumab (Tecentriq, Genentech), the first drug for bladder cancer that utilizes the body’s immune system. The drug will be available by early June.
New treatment for kidney cancer gets OKFDA has approved lenvatinib (Lenvima, Eisai Inc.) in combination with everolimus for the treatment of advanced renal cell carcinoma.
Opdivo snags two new cancer approvalsNivolumab (Opdivo, Bristol-Myers Squibb) received two new approvals from FDA to treat two different cancers.
First drug approved for hallucinations in Parkinson’sFDA approved the first drug to hallucinations and delusions associated with psychosis experienced by some people with Parkinson’s disease.
FDA approves new indication for GilotrifFDA 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.
AbbVie to profit from new Viekira Pak usesFDA 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).
Why FDA pulled cholesterol drugs off marketFDA took the unusual step of withdrawing approval of two cholesterol-lowering drugs late last week.
FDA committee recommends approving rare liver disease drugFDA 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.
New leukemia drug availableFDA 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