September 18, 2014

The Generic Pharmaceutical Association on Thursday provided input on the Generic Drug User Fee Act process before the Food and Drug Administration. 

September 16, 2014

The Food and Drug Administration on Tuesday announced approval for Movantik (naloxegol), a treatment for opioid-induced constipation in adults.

September 15, 2014

Mylan announced that its subsidiary, Mylan Labs Limited, has signed an agreement with Gilead Science under which Mylan has been licensed the non-exclusive rights to manufacture and distribute sofosbuvir and the investigational single-tablet regimen of ledipasvir/sofosbuvir in 91 developing countries. 

September 11, 2014

The Food and Drug Administration approved Contrave (naltrexone hydrochloride and bupropion hydrochloride extended-release tablets) as a chronic weight-management option. 

September 11, 2014

Medivation and Astellas Pharma on Wednesday announced that the Food and Drug Administration approved a new use of Xtandi (enzalutamide) capsules to treat patients with metastatic castration-resistant prostate cancer.

September 10, 2014

The Food and Drug Administration recently announced the availability of the “Purple Book,” which lists biological products in much the same way that the "Orange Book" lists pharmaceuticals. 

September 9, 2014

Sanofi Pasteur announced that the Food and Drug Administration approved the use of Menactra [meningococcal (groups A, C, Y and W-135) polysaccharide diphtheria toxoid conjugate vaccine] as a booster vaccination against meningococcal disease in people ages 15 years through 55 years. 

September 9, 2014

The Food and Drug Administration is on pace to match or exceed the 39 novel new medicines approved in 2012.

September 8, 2014

Mylan is now free to resume distribution of its generic Precedex product (dexmedetomidine hydrochloride injection) to customers, effective immediately. 

September 8, 2014

Silvergate Pharmaceuticals on Monday announced that the Food and Drug Administration approved Epaned (enalapril maleate Powder for oral solution) for the treatment of symptomatic heart failure, as well as the treatment of asymptomatic left ventricular dysfunction. 

September 5, 2014

Merck on Thursday announced that the Food and Drug Administration granted accelerated approval to Keytruda (pembrolizumab) for the treatment of patients with advanced melanoma.

September 5, 2014

Mylan on Friday announced that it has launched a generic version of Hoffmann-La Roche's Boniva injection.

September 4, 2014

Kline Group reported positive signs of 2013 growth across the over-the-counter sector in its recently published Nonprescription Drugs USA study, according to a blog posted Monday

September 2, 2014

UCB on Monday announced that the Food and Drug Administration has approved a supplemental new drug application for Vimpat (lacosamide) C-V as monotherapy in the treatment of partial-onset seizures in patients with epilepsy ages 17 years and older.

September 1, 2014

Pfizer and Protalix BioTherapeutics last week announced that the Food and Drug Administration approved Elelyso (taliglucerase alfa) for injection for pediatric patients.

September 1, 2014

Pfizer last week announced that the Food and Drug Administration has granted fast track designation to the company’s investigational Clostridium difficile (C. difficile) vaccine candidate (PF-06425090). 

August 27, 2014

GlaxoSmithKline announced that the Food and Drug Administration approved its supplemental new drug application for Promacta (eltrombopag), a once-daily medication for patients with severe aplastic anaemia who have had an insufficient response to immunosuppressive therapy.

August 25, 2014

Pharmaceutical company Iroko announced today that a new version its anti-inflammatory drug Zorvolex had been approved by the Food and Drug Administration.

August 25, 2014

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.

August 25, 2014

Nipro Diagnostics announced that the Food and Drug Administration approved its True Metrix self-monitoring blood-glucose system, as well as the True Metrix Pro professional monitoring blood-glucose system.

August 21, 2014

The generic drug industry — and by extension, patients across the United States — is being adversely impacted by what some are calling branded drug makers’ abuse of risk evaluation and mitigation strategies, or REMS.

August 21, 2014

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

August 20, 2014

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.

August 20, 2014

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