The Food and Drug Administration has approved Cerdelga (eliglustat) for the treatment of adult patients with the Type 1 form of Gaucher disease.
The Food and Drug Administration has granted tentative approval for Basaglar (insulin glargine injection), which is used to improve glycemic control in adults with Type 2 diabetes and in combination with mealtime insulin in adults and pediatric patients with Type 1 diabetes.
A coalition of retail groups on Monday filed a joint-merchant petition with the Supreme Court seeking its review of the March 2014 swipe fee decision by the U.S. Court of Appeals for the D.C. Circuit.
Advertising claims for weight loss supplement products feed the Federal Trade Commission with the highest settlement costs within the dietary supplement and functional food category, according to a new web-based, members-only tool from the Council for Responsible Nutrition.
PharmaJet, the developer of a needle-free injection technology to administer medications and vaccines to patients, and bioCSL, the maker of Afluria (influenza vaccine) on Tuesday announced the Food and Drug Administration has approved the PharmaJet Stratis 0.5mL Needle-Free Jet Injector for delivery of Afluria in individuals ages 18 years to 64 years.
The Food and Drug Administration will be hosting an all-day hearing on Sept. 17 seeking public comment on five draft guidance documents related to the implementation of the Generic Drug User Fee Amendments of 2012, as well as input on future policy priorities.
Pfizer’s Prevnar 13 vaccine for pneumonia has been recommended for use by patients 65 years old and up by the Centers for Disease Control and Prevention’s immunization practices advisory committee.
The Food and Drug Administration announced approval of a new use for Avastin (bevacizumab), to treat patients with persistent, recurrent or late-stage cervical cancer.
The Food and Drug Administration has announced approval for Belsomra (suvorexant) tablets, which are used to treat insomnia.
Janssen Pharmaceuticals received approval from the Food and Drug Administration for Invokamet, a fixed-dose therapy that combines canagliflozin and metformin hydrochloride in a single tablet.