March 2, 2011

The Food and Drug Administration is warning that long-term use of a class of drugs for gastroesophageal reflux disease may decrease levels of magnesium in the body and increase the risk of such side effects as seizures and heart rhythm problems, according to published reports.

March 1, 2011

The Food and Drug Administration has approved a treatment for chronic obstructive pulmonary disease made by Forest Labs, the agency said Tuesday.

February 28, 2011

The Food and Drug Administration has approved a GlaxoSmithKline drug for a rare blood disorder, GSK said Friday.

February 28, 2011

The Food and Drug Administration has approved a new use for a Shire drug to treat attention deficit hyperactivity disorder, Shire said Monday.

February 28, 2011

The Food and Drug Administration has approved a treatment for shingles made by a subsidiary of generic drug maker Mylan.

February 28, 2011

British drug maker Shire again is trying to win approval for a hereditary angioedema drug that the Food and Drug Administration had previously declined to approve.

February 28, 2011

The Food and Drug Administration has approved a new treatment for hypertension, also known as high blood pressure, the agency said Friday.

February 25, 2011

More than 400 drugs are in late-stage clinical development or awaiting Food and Drug Administration approval as treatments for rare diseases, according to a report by the drug industry lobby.

February 25, 2011

The Food and Drug Administration has declined to approve a biologic treatment for a rare genetic disorder by Israeli drug maker Protalix Biotherapeutics, Protalix said Friday.

February 25, 2011

Savient said its newest drug is the first and only therapy available to treat chronic gout in adult patients refractory to conventional therapy.

February 25, 2011

Watson Labs is hoping to be the first to market a generic version of a popular drug for attention deficit hyperactivity disorder.

February 24, 2011

Novo Nordisk has filed for approval of a treatment for a rare genetic bleeding disorder, the Danish drug maker said Wednesday.

February 24, 2011

Drug maker Takeda has filed for regulatory approval of a drug to treat hypertension, the company said Wednesday.

February 23, 2011

Biotab Nutraceuticals on Tuesday initiated a voluntary recall of two lots of Extenze nutritional supplement tablets.

February 23, 2011

Drug maker Forest Labs plans to acquire the developer of a recently approved antidepressant.

February 23, 2011

The makers behind a popular Type 2 diabetes treatment have included data from two clinical studies in an update to the drug's prescribing information.

February 22, 2011

Generic drug maker Hi-Tech Pharmacal has received Food and Drug Administration approval for its version of a drug used to treat neurological disorders, the company said Tuesday.

February 22, 2011

Generic drug maker Perrigo has filed for approval of a drug to treat psoriasis with the Food and Drug Administration.

February 22, 2011

Prasco Labs will distribute an authorized generic version of an ulcerative colitis treatment made by Shire in the event that any other company steps forward to file an abbreviated new drug application for the drug.

February 18, 2011

Though efforts to repeal the Patient Protection and Affordable Care Act via the court system remain under way — with recent victories for opponents in Virginia and Florida — the attempt to repeal the healthcare-reform bill in Congress failed, thus leaving the bill and, most importantly, the regulatory approval pathway for follow-on biologics intact.


February 18, 2011

A whole slew of drugs will lose patent protection this year, opening up opportunities for generic drug makers to market their own versions. Most notable among these is Pfizer’s cholesterol-
lowering drug Lipitor (atorvastatin), the world’s top-selling drug, with U.S. sales of $7 billion during the 12 months ended September 2010, according to IMS Health.


February 18, 2011

The Food and Drug Administration has approved a treatment for a rare bleeding disorder.

February 18, 2011

An asthma drug widely available as a generic should not be used for preventing or treating preterm labor in pregnant women, the Food and Drug Administration warned.

February 18, 2011

A generic drug maker received regulatory approval from the Food and Drug Administration for its generic version of a bacterial infection treatment.