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.

May 31, 2012

As the Food and Drug Administration works to finalize draft guidance related to the development of biosimilar products, pharmacy groups recently weighed in with recommendations to facilitate the entry of lower-cost products into the biologic and specialty pharmaceutical markets.

May 31, 2012

Tris Pharma on Thursday announced that the Food and Drug Administration has approved its generic equivalent to Reckitt Benckiser's Delsym, an extended-release oral liquid suspension containing dextromethorphan.

May 30, 2012

The Food and Drug Administration has approved a branded acne drug made by Ranbaxy Labs, the drug maker said.

May 30, 2012

A counterfeit version of a Teva Pharmaceutical Industries attention deficit hyperactivity disorder and narcolepsy drug is circulating online, regulators warned Tuesday.

May 30, 2012

The House of Representatives will be debating H.R. 5651 Wednesday afternoon — a bill that, if passed, will reauthorize the Prescription Drug User Fee Act.

May 29, 2012

An experimental drug made by Pfizer for a rare and fatal neurodegenerative disease got a favorable vote from a Food and Drug Administration expert panel.

May 29, 2012

Mylan on Tuesday announced that its subsidiary has received final approval from the Food and Drug Administration for its abbreviated new drug application for atorvastatin calcium tablets, a generic version of Pfizer's Lipitor.

May 29, 2012

Dietary supplement industry champion Sen. Orrin Hatch, R-Utah, last week led efforts to strike down an amendment that would have dramatically overregulated the dietary supplement industry.

May 29, 2012

Generic drug maker Watson Pharmaceuticals has entered a settlement that will allow it to launch a generic patch used to treat post herpetic neuralgia, a pain disorder associated with shingles.

May 24, 2012

Two drug makers are looking to win approval for an experimental drug in patients with colorectal cancer that has spread to other parts of the body.

May 24, 2012

A Food and Drug Administration expert panel has recommended against expanding the approval of a Johnson & Johnson drug, the company said.

May 24, 2012

The generic drug industry has applauded the passage of legislation that will expedite the Food and Drug Administration's review of generic drugs and biosimilars, as well as enhance the agency's ability to inspect foreign manufacturing sites.

May 24, 2012

Following the Senate’s defeat of a proposal that would have permitted “personal importation” of prescription drug medications, the National Association of Chain Drug Stores lauded the Senate’s decision to support patient safety.

May 24, 2012

The $317 billion problem of medication nonadherence has many sources that often combine and overlap in complex ways. But fears of whether a drug is safe and will work are among of the most frequently cited reasons why patients don't take their drugs as prescribed, or don't take them at all.

May 23, 2012

Food and Drug Administration drug warnings can have an immediate negative impact on medication adherence among patients, even if the warnings are not safety related, according to new research sponsored by CVS Caremark.

May 23, 2012

A generic antiretroviral drug for treating HIV infection has won approval from the Food and Drug Administration.

May 23, 2012

The Food and Drug Administration has approved a new treatment for acne made by a GlaxoSmithKline subsidiary.