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.

August 20, 2014

While drug stores across North America have diversified their mix over the past few years, over-the-counter medications remain at the heart of most every pharmacy retailer’s efforts, helping to maintain the drug channel’s inherent value as a front-line healthcare provider and the outlet of choice for consumers suffering from a wide range of minor illnesses.

August 20, 2014

Greater consumer awareness about sun safety and the harmful effects of soaking up too many rays has helped boost the sun care segment, but experts will no doubt tell you that there remains much room for improvement.

August 19, 2014

About 30% of top-performing OTC drugs today were once prescription-only medications, Dave Wendland, VP Hamacher Resource Group, noted during a videocast hosted by GMDC, titled “Rx-to-OTC: Getting it Right at Retail.”

August 19, 2014

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

August 19, 2014

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.

August 18, 2014

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. 

August 15, 2014

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.

August 14, 2014

The Food and Drug Administration has announced approval for Belsomra (suvorexant) tablets, which are used to treat insomnia.

August 11, 2014

The recent release of Colgate Total’s application submitted to the Food and Drug Administration, which included 35 pages summarizing toxicology studies on triclosan, is raising some eyebrows as some are wondering if the FDA did its due diligence in approving Total 17 years ago, according to a report from Bloomberg Businessweek.

August 11, 2014

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.

August 11, 2014

The Food and Drug Administration last week released a draft guidance to assist sponsors and other interested parties in providing information that will help the agency determine the exclusivity period for biologics approved under Section 351(a) of the Public Health Service Act, Bloomberg BNA reported.

August 8, 2014

The Food and Drug Administration earlier this week announced approval for Orbactiv (oritavancin), an antibacterial drug used to treat patients with acute bacterial skin and skin structure infections.

August 6, 2014

Michael Taylor, who currently serves as the Food and Drug Administration's deputy commissioner for foods and veterinary medicine, outlined the importance for companies to adhere to gluten-free guidelines in a post on FDA Voice.

August 4, 2014

The Council for Responsible Nutrition on Friday submitted comments to the Food and Drug Adminisration regarding the agency's proposed rule changes of nutrition and supplement facts labels.