12/30/2014 - 12:17pm

Vertex Pharmaceuticals has announced that the Food and Drug Administration approved a supplemental new drug application for the use of Kalydeco (ivacaftor) in people with cystic fibrosis ages 6 years and older who have the R117H mutation in the cystic fibrosis transmembrane conductance regulator gene.

12/29/2014 - 12:26pm

Genentech last week announced that the Food and Drug Administration approved a supplemental biologics license application for Gazyva to be used in combination with chlorambucil chemotherapy in people with previously untreated chronic lymphocytic leukemia.

12/29/2014 - 11:46am

In a staff memo, the Office of Generics Drug’s acting director, Kathleen Uhl, vowed to take action on 90% of the abbreviated new drug application backlog before October 2017, and has appointed Ted Sherwood as acting director of OGD’s Office of Regulatory Operations to help with the improvements, FDANews.com has reported.

12/29/2014 - 11:29am

Novo Nordisk last week announced that the Food and Drug Administration approved the company's new drug application for Saxenda, a once-daily glucagon-like peptide-1 receptor agonist used as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adults.

12/18/2014 - 4:10pm

As out-of-pocket expenses rise, many Americans say that the affordability of basic medical care is a hardship and, as a result, some are forgoing treatment because they are worried about cost, according to a recent national poll conducted by The New York Times and CBS News.

12/18/2014 - 12:59pm

The U.S. Senate Special Committee on Aging unveiled a new bipartisan report earlier this week that focuses on ways to increase the use of generic drugs within the Medicare Part D program.

12/17/2014 - 4:49pm

The Food and Drug Administration on Wednesday approved Xtoro (finafloxacin otic suspension), a new drug that's used to treat acute otitis externa, commonly known as swimmer's ear. 

12/17/2014 - 12:24pm

To date, the Food and Drug Administration's Center for Drug Evaluation and Research has approved 35 novel new drugs in 2014, compared to 27 in 2013. 

12/16/2014 - 12:32pm

Use of cigarettes, alcohol and abuse of prescription pain relievers among teens has declined since 2013, while marijuana use rates were stable, according to the 2014 Monitoring the Future survey, released Tuesday.