Content about Clinical research

July 16, 2013

Mylan has launched a generic contraceptive therapy, the drug maker said Tuesday.

July 12, 2013

Actavis is looking to become the first to market a generic drug for epilepsy, the company said.

July 12, 2013

The Food and Drug Administration has approved a new lung cancer drug made by Boehringer Ingelheim, the agency said.

July 12, 2013

The creation of a clear approval pathway for biosimilar drugs remains a daunting task for the Food and Drug Administration, despite the fact that it's prescribed by law through the Patient Protection and Affordable Care Act. But when those lower-priced, generic versions of some staggeringly expensive bioengineered medicines do finally come to market, they're likely to have a profound effect on the nation's outlays for specialty pharmaceuticals.

July 12, 2013

The Indian generic drug maker announced the approval of repaglinide tablets in the 1-mg and 2-mg strengths, which are used in combination with diet and exercise to improve blood-sugar control in patients with Type 2 diabetes.

July 9, 2013

A total of 27 members of Congress issued a kind reminder to the Food and Drug Administration that many leaders across Capitol Hill are keeping tabs on New Dietary Ingredient guidance.

July 9, 2013

Mylan has received tentative approval for a generic version of a cholesterol drug made by AstraZeneca, according to Food and Drug Administration records.

July 9, 2013

The Food and Drug Administration has approved a new drug for treating opioid dependence.

July 9, 2013

The U.S. healthcare system has saved $25.5 billion over seven years from generic drugs launched under patent settlements between branded and generic drug manufacturers, according to a new study.

July 8, 2013

Impax Labs has appointed Mary Pendergast to its board of directors, the generic drug maker said.

July 2, 2013

The Food and Drug Administration has approved a gel formulation of a foot fungus drug made by Merz Pharmaceuticals, according to published reports.

July 2, 2013

Sandoz has started a late-stage clinical trial of a biosimilar version of a drug used to treat autoimmune disorders, hoping the results will support its efforts to win regulatory approval in the United States and Europe.

July 1, 2013

CVS/pharmacy has bolstered its mobile app by adding the new Drug Interaction Checker, which is an industry first that allows customers to easily check for potential drug interactions by comparing OTC products with their prescriptions and other OTCs on their smartphones.

July 1, 2013

The Food and Drug Administration has declined to approve a sleeping pill made by Merck & Co., citing issues with dosage.

June 27, 2013

The Food and Drug Administration has approved what's being called the first therapy of its kind to prevent bleeding episodes.

June 26, 2013

The Food and Drug Administration has approved a drug made by Astellas Pharma for treating fungal infections in children.

June 26, 2013

Mylan has launched a generic version of a Johnson & Johnson contraceptive, the company said Wednesday.

June 25, 2013

Drug makers may be allowed to seek approval for a generic version of an eye drug made by Allergan based on lab tests rather than clinical trials, according to published reports.

June 21, 2013

The Food and Drug Administration has approved a contraceptive pill for all women of childbearing potential without a prescription, the agency said.

June 18, 2013

The Food and Drug Administration's Center for Drug Evaluation and Research has collected 84% of the fees it intends to collect this year under a law passed last year to collect user fees from generic drug members, according to a memo sent out to CDER staff Tuesday.

June 17, 2013

Patent settlements between brand and generic drug makers commonly referred to as "pay-for-delay" settlements are not necessarily against the law, the Supreme Court ruled Monday.

June 13, 2013

The Food and Drug Administration has approved a drug made by Amgen for treating a rare and usually noncancerous bone tumor, the agency said Thursday.

June 10, 2013

A 26-member joint panel comprising the Food and Drug Administration's Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management advisory committees voted to support modifying or removing the risk evaluation and mitigation strategy protocol for GlaxoSmithKline's Type 2 diabetes drug Avandia (rosiglitazone).

Historically, the FDA has followed advisory committee votes when making a decision on the marketing of a drug even though it is not bound by them, but assuming the agency follows the panel's advice, it could mean a lot for the controversial drug and the way it's dispensed. But even if Avandia winds up on retail pharmacy shelves again, it faces a very different landscape from its heyday.

June 6, 2013

The Food and Drug Administration has approved a drug made by Celgene for treating a type of cancer.

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