Regulatory and Washington

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug made by Actelion Pharmaceuticals for treating pulmonary arterial hypertension.

The agency announced the approval of Opsumit (macitentan) for adults with PAH, a chronic, progressive and debilitating disease caused by high blood pressure in the arteries that connect the heart to the lungs that can lead to death or the need for lung transplantation.

DARMSTADT, Germany — The Food and Drug Administration has approved a pre-filled injector pen made by EMD Serono for infertile women, the company said Friday.

The drug maker — the U.S. subsidiary of Germany's Merck Serono, so-called to distinguish it from U.S.-based Merck & Co. — announced the approval of Gonal-f RFF Redi-ject (follitropin alfa), a disposable pre-filled injector pen intended for injection under the skin of a liquid formulation of Gonal-f RFF. The pens will be available in the United States in December.

ATLANTA — The Food and Drug Administration has approved a drug made by UCB for treating a form of arthritis.

The drug maker said Friday that the FDA had approved Cimzia (certolizumab pegol) for adults with active ankylosing spondylitis, though it declined to approve the drug for axial spondyloarthritis, or axSpA. UCB said it was working with the agency to determine how to get the drug approved for axSpA.

NEW YORK — The overall prevalence of obesity among adults remained unchanged between 2009 and 2012, according to new data from the Centers for Disease Control and Prevention.

NEW YORK — As knock-off versions of biotech drugs get closer to reality in the United States, one issue that has emerged has centered on what to call them.

BAGSVÆRD, Denmark — The Food and Drug Administration has approved a new drug made by Novo Nordisk for treating hemophilia A, the Danish drug maker said.

Novo Nordisk announced the approval of Novoeight (turoctocog alfa), a recombinant coagulation factor VIII, for adults and children with hemophilia, a disease caused by factor VIII deficiency that results in uncontrollable bleeding.

WASHINGTON — Nearly two dozen women with heart disease will educate their communities about heart disease in women.

WASHINGTON, D.C. — Matthew Shay, president and CEO of the National Retail Federation, released a statement on the decision to reopen the federal government through Jan. 15 and raise the debt ceiling until Feb. 7. Shay said that while the agreement provides some satisfaction, it essentially continues debate and postpones difficult economic decisions that must be made.