08/25/2014 - 11:56am

ViiV Healthcare announced that the Food and Drug Administration has approved Triumeq (abacavir 600 mg, dolutegravir 50 mg and lamivudine 300 mg) tablets for the treatment of HIV-1 infection.

08/22/2014 - 11:11am

Mylan on Friday announced the launch of potassium chloride extended-release tablets USP in 600-mg and 750-mg dosage strengths.

08/21/2014 - 5:18pm

The Food and Drug Administration cleared South Korean company Philosys’ Gmate blood-sugar monitoring device for U.S. marketing on Aug. 15.

08/21/2014 - 1:48pm

GlaxoSmithKline announced FDA approval for Arnuity Ellipta (fluticasone furoate inhalation powder), a once-daily inhaled corticosteroid medicine for the treatment of asthma in patients 12 years of age and older.

08/20/2014 - 6:42pm

Despite creating a detailed plan to speed up the rate at which generic drug applications are reviewed, experts say a backlog has developed at the Food and Drug Administration’s Office of Generic Drugs.

08/20/2014 - 12:33pm

The Food and Drug Administration has approved Cerdelga (eliglustat) for the treatment of adult patients with the Type 1 form of Gaucher disease.

08/20/2014 - 9:36am

Carma Labs on Wednesday announced the launch of Carmex Cold Sore Treatment. 

08/19/2014 - 1:02pm

The Food and Drug Administration has approved Mylan Institutional’s application for its dexmedetomidine hydrochloride injection, the company announced Tuesday. 

08/19/2014 - 12:04pm

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.