July 14, 2014

Although the pace of approvals for new orphan drugs — medicines that treat relatively rare conditions — have increased in the United States and Europe in recent years, patients are facing growing challenges accessing those drugs, a newly completed study released last week by the Tufts Center for the Study of Drug Development at Tufts University has concluded.

April 23, 2014

Bayer HealthCare on Tuesday announced that the Food and Drug Administration's Office of Orphan Products Development has granted orphan drug designation for Bayer's investigational Ciprofloxacin Dry Powder for Inhalation (Ciprofloxacin DPI) for the treatment of non-cystic fibrosis bronchiectasis.

April 22, 2014

Eli Lilly on Monday announced that the Food and Drug Administration has approved Cyramza (ramucirumab) as a single-agent treatment for patients with advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy.

April 21, 2014

Boehringer Ingelheim Pharmaceuticals has announced that the Food and Drug Administration and European Commission have granted Orphan Drug Designation to volasertib for acute myeloid leukemia.

December 2, 2013

The Food and Drug Administration has designated a drug made by Teva Pharmaceutical Industries as an orphan drug, the company said.

November 15, 2013

The Food and Drug Administration has given orphan drug designation to an experimental treatment for a rare form of epilepsy.

November 13, 2013

The Food and Drug Administration has given special designation to a drug under development by Mast Therapeutics for a rare disease that restricts the flow of blood to the limbs.

October 21, 2013

The Food and Drug Administration is offering more than $14 million in grants for the development of products for patients with rare diseases, the agency said.

June 25, 2013

The Food and Drug Administration has given special designation to a drug made by Raptor Pharmaceuticals for a rare metabolic disease.

February 14, 2013

The Food and Drug Administration has granted special designation to a drug made by Eisai for treating thyroid cancer.

December 6, 2012

The Food and Drug Administration has given special designation to a treatment made by Biodel for patients with congenital hyperinsulinism, a rare disorder that affects children.

September 26, 2012

A drug maker is suing the Food and Drug Administration to force the agency to give a special designation to one of its drugs.

May 3, 2012

Drug makers could strike big with new treatments for rare diseases, according to a new report by a market research firm.

August 2, 2011

The Food and Drug Administration has granted orphan drug designation to a chemotherapy drug made by Merrimack Pharmaceuticals for pancreatic cancer, the drug maker said Monday.

July 12, 2011

The Food and Drug Administration has granted orphan drug designation to a cancer treatment in mid-stage development made by German drug maker 4SC, the company said Tuesday.

June 8, 2011

The Food and Drug Administration has granted orphan drug designation to an investigational treatment made by Edison Pharmaceuticals for rare diseases, Edison said Wednesday.

June 1, 2011

The Food and Drug Administration has given orphan drug designation to an investigational treatment for multiple myeloma, a blood cell cancer, that soon will enter mid-stage development.

May 9, 2011

The Food and Drug Administration has granted orphan drug designation to a treatment made by Mithridion for a rare neurological disorder, Mithridion said Monday.

November 15, 2010

The Food and Drug Administration has granted orphan drug designation to a drug for treating...

October 14, 2010

The Food and Drug Administration has given orphan drug designation to a treatment for a...

August 18, 2010

Swiss drug maker Biogen Idec will develop and commercialize an investigational drug as a treatment...

July 14, 2010

The Food and Drug Administration has given special designation to an investigational treatment for a...

July 12, 2010

The 5th Annual Rare Disease Leadership Summit being held Wednesday in Arlington, Va., will feature...

May 23, 2010

The Food and Drug Administration has granted special designation to encourage the development of a...