February 8, 2013

The Food and Drug Administration has given tentative approval to a generic drug for treating hypertension, according to agency records.

February 8, 2013

A new switch paradigm could open the door to $35.7 billion in OTC opportunity, according to a new report recently released by Francesco International.

February 6, 2013

The Food and Drug Administration has approved a regulatory approval application from Elite Pharmaceuticals for an opioid painkiller, the drug maker said Wednesday.

February 6, 2013

The Food and Drug Administration has approved a generic antibiotic made by Sandoz, the drug maker said Wednesday.

February 6, 2013

Republican and Democratic senators have re-introduced legislation that would ban patent settlements between branded and generic drug companies that critics allege violate antitrust laws, according to published reports.

February 5, 2013

A new report sheds light on some of the opportunities and challenges that exist in follow-on biologics, arguing that their opportunity to generate value depends on factors like the speed of development, clarity of regulation, ease of access and the roles of all stakeholders.

February 4, 2013

The Food and Drug Administration has approved a generic version of a cancer drug in a move that the agency said would help relieve shortages.

February 4, 2013

Walgreens on Monday made available a new application programming interface that allows third-party mobile app developers to integrate the drug store chain’s prescription refill technology.

February 1, 2013

The Food and Drug Administration has approved a new drug for treating some disorders that harm the body's ability to remove ammonia from the blood, the agency said Friday.

January 28, 2013

The Food and Drug Administration has accepted a regulatory approval application from Genzyme for an experimental treatment for multiple sclerosis, the company said Monday.

January 28, 2013

The Food and Drug Administration has approved a new use for a pneumococcal vaccine made by Pfizer, the drug maker said.

January 25, 2013

The Food and Drug Administration has approved a Novartis drug for treating leukemia in children.

January 25, 2013

The Food and Drug Administration has approved a new use for a cancer drug made by Roche unit Genentech, the agency said.

January 23, 2013

The Food and Drug Administration has approved a new drug for removing excess iron from the blood in patients with a rare genetic disorder, the agency said.

January 22, 2013

The Food and Drug Administration has approved a generic contraceptive made by Lupin Pharmaceuticals, the drug maker said Tuesday.

January 21, 2013

Drug maker GlaxoSmithKline is seeking Food and Drug Administration approval for a new treatment for Type 2 diabetes, the drug maker said.

January 21, 2013

While regulations for biosimilars work their way through the Food and Drug Administration, state governments are already looking at legislation concerning the substitution of biosimilars for their branded counterparts, according to a legal affairs blog focused on the FDA.

January 18, 2013

The Food and Drug Administration is allowing Roche to tap its reserves of the flu drug Tamiflu, according to published reports.

January 17, 2013

The Food and Drug Administraiton has approved a drug for replacing clotting proteins in the blood for conditions in which patients have too little of them.

January 11, 2013

A panel of Food and Drug Administration experts has recommended approval for an experimental Type 2 diabetes drug made by Johnson & Johnson, the drug maker said.

January 10, 2013

The Food and Drug Administration is ordering the makers of several sleep drugs to lower the dosage due to the risk that they can impair patients the morning after, the agency said Thursday.

January 8, 2013

Biotech companies saw a decline in project delays due to regulations over the past year, as more than half have said insurance coverage and reimbursement issues have become more difficult, according to a new report.

January 8, 2013

The Food and Drug Administration on Tuesday advised consumers not to purchase or use “MAXILOSS Weight Advanced” — a product promoted and sold for weight loss on various web sites, including DreamLifeWeightLoss.com, and in some retail stores.

January 4, 2013

The Food and Drug Administration has approved a new means of administration for a multiple sclerosis drug, the manufacturers said.