March 12, 2012

One of the long-term goals of many drug companies has been to win Food and Drug Administration approval for cholesterol-lowering statins as over-the-counter drugs. But it's a goal that has long eluded them due to the agency's concerns about patient safety.

February 23, 2012

The Food and Drug Administration has accepted a new drug application for the treatment of idiopathic Parkinson’s disease.

January 18, 2012

The Food and Drug Administration has provided guidance to Provectus Pharmaceuticals as the drug maker prepares to apply with the agency for approval to start a late-stage clinical trial of a drug for skin cancer, Provectus said Wednesday.

December 20, 2011

Pfizer is seeking approval from the Food and Drug Administration for its investigational treatment of moderately to severely active rheumatoid arthritis.

November 10, 2011

The Food and Drug Administration has accepted a new drug application for a skin cancer treatment developed by Roche.

November 4, 2011

If the ultimate goal of the Affordable Care Act is to save money and expand patient care, then making patients visit their physicians and get prescriptions just to get reimbursed for over-the-counter medications — which wastes money, as well as the time of physicians, a precious commodity when the country is set to have a shortage of them — makes no sense.

October 28, 2011

The Food and Drug Administration has approved a supplemental new drug application related to a drug made by Abbott, the company said.

October 11, 2011

The Food and Drug Administration has approved Mylan’s promethazine hydrochloride tablets, a generic drug for treating allergies, in the 12.5-mg, 25-mg and 50-mg strengths.

September 7, 2011

The Food and Drug Administration has accepted a regulatory approval application for a drug made by Vivus for treating erectile dysfunction.

August 19, 2011

NexMed USA on Thursday received clearance from the Food and Drug Administration to market the company's first over-the-counter antifungal drug, Tolnaftate-D.

July 14, 2011

The National Association of Chain Drug Stores announced on Thursday its support of legislation that seeks to repeal a provision of the Patient Protection and Affordable Care Act, which requires consumers to obtain a prescription to use their flexible spending accounts for over-the-counter medication purchases.

May 23, 2011

Generic drug maker Par has inked a definitive agreement to acquire an India-based developer and manufacturer of generic drugs.

May 19, 2011

Theodore Kaczynski, also known as the Unabomber, allegedly is a suspect in the 1982 Tylenol poisonings in the Chicago area that killed seven people, according to published reports.

May 10, 2011

The branded-drug division of Impax Labs plans to conduct early-stage clinical studies of an investigational drug for restless leg syndrome, the company said Tuesday.

April 21, 2011

GlaxoSmithKline and Valeant last week responded to the Food and Drug Administration's complete response letter for the companies' investigational anti-epileptic drug.

April 12, 2011

Perrigo on Tuesday announced that the Detroit office of the Food and Drug Administration has concluded its re-inspection of Perrigo's Allegan facility.

March 8, 2011

The Food and Drug Administration has accepted a regulatory approval application for a Type 2 diabetes drug from Bristol-Myers Squibb and AstraZeneca, the two drug makers said Tuesday.

November 9, 2010

Walgreens on Wednesday released a survey that found 2-in-5 American households have at least one...

October 10, 2010

The new prescription requirement for over-the-counter medicines under flexible spending accounts, part of the new...

October 4, 2010

Parents’ confusion over correctly administering over-the-counter medication to their children appears to be shared worldwide,...

October 3, 2010

A local supermarket chain is offering $4 prescription and over-the-counter medications at its pharmacies....

September 21, 2010

The Special Interest Group for IIAS Standards announced Wednesday that the group is making significant...

August 11, 2010

An investigational drug made by Pharmasset for treating hepatitis C will get expedited review from...

July 20, 2010

Fera Pharmaceuticals has acquired rights to an investigational drug for treating a rare fungal ear...