June 21, 2012

Faced with the possibility of a critical cutoff in funding for the Food and Drug Administration, Congress moved in late May to reauthorize the Prescription Drug User Fee Act that provides the bulk of the agency’s resources for new-drug review and approval. 


June 21, 2012

It’s been cited as one of the biggest health crises facing the United States and, if solved, the equivalent dollar value of a blockbuster drug. According to the latest statistics from pharmacy benefit manager Express Scripts, poor medication adherence costs the country $317 billion per year, an upgrade from the $290 billion calculated in a study released in 2009 by the New England Healthcare Institute.


June 21, 2012

Manufacturers of sunscreen now will have six additional months to meet the new labeling and testing requirements as imposed by the Food and Drug Administration, according to an announcement from the Federal Register.

June 21, 2012

In 2008, an investigation by the Associated Press revealed that drinking water supplies in major cities and metropolitan regions across the country are riddled with pharmaceutical compounds.

June 20, 2012

The Council for Responsible Nutrition on Wednesday commended the Food and Drug Administration for its plans to reissue a revised New Dietary Ingredient Notification Draft Guidance.

June 20, 2012

The National Association of Chain Drug Stores on Wednesday urged Congress to pass the Prescription Drug User Fee Act, legislation essential to the review process for new medications and that also contains important pro-patient, pro-pharmacy provisions.

June 19, 2012

The Food and Drug Administration has declined to approve a drug designed to treat a rare, progressive and fatal neurodegenerative disease.

June 15, 2012

The Council for Responsible Nutrition on Thursday issued a response to a U.S. Preventive Services Task Force draft recommendation around the ineffectiveness of vitamin D and calcium to prevent cancer or fractures.

June 15, 2012

GlaxoSmithKline has received regulatory approval from the Food and Drug Administration for a vaccine designed to prevent invasive disease caused by Neisseria meningitidis serogroups C and Y and Haemophilus influenzae type B.

June 14, 2012

Cellceutix on Wednesday reported that the Food and Drug Administration granted a section 505(b) designation for its Prurisol treatment for psoriasis, which would allow the company to forgo early-stage trials and advance Prurisol into latter-stage clinical trials.

June 13, 2012

Merck on Wednesday released new data from two pivotal Phase III efficacy trials for suvorexant, the investigational medicine Merck is developing for the treatment of insomnia.

June 13, 2012

As the U.S. Senate and House reconcile their versions of the Prescription Drug User Fee Act, the National Association of Chain Drug Stores on Wednesday urged U.S. House and Senate leaders to expand provisions in the final bill to help ensure that Americans continue to have access to safe and effective prescription medications, while also curbing prescription drug abuse.

June 12, 2012

A Sanofi company is seeking regulatory approval from the Food and Drug Administration for a drug designed to treat relapsing multiple sclerosis.

June 11, 2012

With overwhelming support in both the U.S. House and Senate and the strong backing of President Obama, a reauthorization of the landmark Prescription Drug User Fee Act that funds new drug application reviews at the Food and Drug Administration is a near certainty, probably within days or weeks at most. But one amendment to the Senate's version of PDUFA reauthorization, contained in the Food and Drug Administration Safety Innovation Act, could threaten both retail pharmacies and the patients they serve.

June 11, 2012

Avanir Pharmaceuticals confirmed that the Food and Drug Administration has accepted the company's investigational new drug application for an Alzheimer's disease drug.

June 11, 2012

Genentech has received regulatory approval for a drug designed to treat breast cancer.

June 7, 2012

The Food and Drug Administration has approved a drug made by GlaxoSmithKline and XenoPort for treating pain associated with shingles.

June 7, 2012

The Food and Drug Administration has approved a drug for kidney disease made by Perrigo.

June 5, 2012

The Food and Drug Administration has approved a new dosage of an antibiotic drug made by Lupin Pharmaceuticals, Lupin said Tuesday.

June 5, 2012

An interactive health-and-wellness screening kiosk for consumers has received regulatory approval from the Food and Drug Administration.

June 1, 2012

Five pharmacy organizations on Thursday wrote Congress in opposition of an amendment to the Food and Drug Administration Safety Innovation Act due to its potential to delay patients' timely relief from chronic pain while increasing drug costs.

May 31, 2012

The Food and Drug Administration on Thursday warned parents against administering benzocaine to their teething babies and advised that parents not use benzocaine at all in children under the age of 2 years unless under the supervision of a family physician.

May 31, 2012

The House of Representatives on Wednesday passed legislation that reauthorizes the Food and Drug Administration’s prescription drug user fee programs that are scheduled to expire in September. H.R. 5651 passed the House by a vote of 387 to 5.

May 31, 2012

A Johnson & Johnson subsidiary is seeking approval for a Type 2 diabetes treatment.