FDA Approvals

Magnetic Stimulation Device Approved to Treat Obsessive Compulsive Disorder

FRIDAY, Aug. 17, 2018 -- The Brainsway Deep Transcranial Magnetic Stimulation System has been approved by the U.S. Food and Drug Administration to treat obsessive compulsive disorder (OCD).

OCD is a chronic condition characterized by uncontrollable, recurring thoughts and actions that a person feels the need to continually repeat. Government statistics show about 1 percent of people in the United States had OCD in the past year, the FDA said Friday in a news release.

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New Treatment for Non-Hodgkin Lymphoma Approved

WEDNESDAY, Aug. 8, 2018 -- Poteligeo (mogamulizumab) injection has been approved by the U.S. Food and Drug Administration to treat adults with two types of non-Hodgkin lymphoma.

The drug was approved to treat relapsed or refractory mycosis fungoides (MF) and Sézary syndrome (SS) after the patient has had at least one prior therapy delivered through the bloodstream.

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Azedra Approved for Rare Adrenal Tumors

TUESDAY, July 31, 2018 -- Azedra (iobenguane) has been approved by the U.S. Food and Drug Administration to treat people 12 and older with rare adrenal gland tumors that can't be surgically removed and have spread beyond the original site.

The adrenal glands sit above the kidneys and produce the stress hormones epinephrine and norepinephrine. The rare tumors known as pheochromocytomas spike production of these hormones, leading to possible symptoms including high blood pressure, headache, irritability, excessive sweating and rapid heartbeat. Sometimes, such tumors develop outside the adrenal gland, where they're called paragangliomas, the FDA said in a news release.

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Magnetic System Approved for Guiding Lymph Biopsies

WEDNESDAY, July 25, 2018 -- A magnetic system for guiding lymph node biopsies in certain people with breast cancer has been approved by the U.S. Food and Drug Administration.

The Sentimag System uses magnetic detection during a sentinel lymph node biopsy to identify certain lymph nodes for removal, the agency said in a news release.

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Tibsovo Approved for Acute Myeloid Leukemia

FRIDAY, July 20, 2018 -- Tibsovo (ivosidenib) tablets have been approved by the U.S. Food and Drug Administration to treat relapsed or refractory acute myeloid leukemia (AML) among people with a defective IDH1 gene.

"The use of Tibsovo is associated with a complete remission in some patients and a reduction in the need for both red cell and platelet transfusions," said Dr. Richard Pazdur, director of the FDA's Oncology Center of Excellence.

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First Drug to Treat Smallpox Approved

MONDAY, July 16, 2018 -- TPOXX (tecovirimat) has been approved by the U.S. Food and Drug Administration to treat smallpox.

Though the contagious and often-deadly viral disease was considered eradicated by the World Health Organization in 1980, there are concerns that smallpox could be used in a terrorist attack.

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1st 'Biosimilar' OK'd to Prevent Chemo-Related Infections

TUESDAY, June 5, 2018 -- The first "biosimilar" drug to Neulasta, designed to ward off infections related to chemotherapy, has been approved by the U.S. Food and Drug Administration.

Fulphila (pegfilgrastim) is approved for people with symptoms of febrile neutropenia, which is characterized by fever and other signs of infection such as low white-blood-cell count, the FDA said in a news release. People receiving immune-system suppressing chemotherapy for non-bone marrow cancer are at heightened risk for febrile neutropenia, the agency added.

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New Treatment for Ulcerative Colitis Approved

WEDNESDAY, May 30, 2018 -- U.S. Food and Drug Administration approval of Xeljanz (tofacitinib) has been expanded to include adults with active moderate-to-severe ulcerative colitis, the agency said Wednesday.

Ulcerative colitis (UC) is a chronic inflammatory bowel disease, characterized by recurring flares of abdominal pain and bloody diarrhea. Symptoms also may include fatigue, weight loss and fever.

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First Artificial Iris is Approved

WEDNESDAY, May 30, 2018 -- The first artificial iris to replace the colored section of the eye that surrounds the pupil has been approved by the U.S. Food and Drug Administration.

Many people who are candidates for the device were born with a condition called aniridia, a rare genetic disorder in which the iris is missing or damaged. The condition affects 1 in 50,000 to 100,000 people in the United States, the FDA said Wednesday in a news release.

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New Treatment Approved for Rare Disease PKU

FRIDAY, May 25, 2018 -- Palynziq (pegvaliase-pqpz) has been approved by the U.S. Food and Drug Administration to treat phenylketonuria, commonly called PKU.

People with the rare yet serious inherited disorder can't break down an amino acid called phenylalanine, which is found in many sweeteners and protein-containing foods.

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