FDA Approvals

New Hemophilia Treatment Stems Bleeding Episodes

THURSDAY, Nov. 16, 2017 -- Hemlibra (emicizumab-kxwh) has been approved by the U.S. Food and Drug Administration to prevent or reduce the number of bleeding episodes among certain people with hemophilia A.

The injected drug was approved for patients with antibodies called Factor VIII inhibitors. People with hemophilia A are missing a gene that produces Factor VIII, a blood-clotting protein.

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Mepsevii Approved for Rare Enzyme Disorder

WEDNESDAY, Nov. 15, 2017 -- Mepsevii (vestronidase alfa-vjbk) has been approved by the U.S. Food and Drug Administration to treat a rare, genetic disorder called mucopolysaccharidosis type VII, sometimes called Sly syndrome.

Affecting fewer than 150 people worldwide, the extremely rare disorder typically causes various skeletal abnormalities that worsen with age, including short stature. Life expectancy and symptoms and vary widely, but also may include heart valve problems, enlarged liver and narrowed respiratory airways, the agency said Wednesday in a news release.

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'Digital Pill' Tells Doctor When Patient Takes It

TUESDAY, Nov. 14, 2017 -- The first drug designed to alert a doctor when a patient takes the medication has been approved by the U.S. Food and Drug Administration.

Abilify MyCite (aripiprazole with sensor) has an embedded sensor that sends a message to a wearable patch that the medication's been taken. This allows the patient and doctor to track the medication's use via smartphone.

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Zelboraf Approved for Rare Blood Cancer

MONDAY, Nov. 6, 2017 -- Zelboraf (vemurafenib) has been approved by the U.S. Food and Drug Administration as the first drug to treat Erdheim-Chester Disease, a rare but deadly blood cancer. The approval covers patients who have a genetic mutation called BRAF V600.

Erdheim-Chester Disease is a slow-growing cancer that originates in bone marrow, causing a spike in a type of white blood cell called a histiocyte. This can spur tumors that develop in the heart, lung, brain and elsewhere, the FDA said Monday in a news release. The cancer only affects about 700 people worldwide, about half of whom have the BRAF V600 mutation.

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Calquence Approved for Mantle Cell Lymphoma

TUESDAY, Oct. 31, 2017 -- Calquence (acalabrutinib) has been approved by the U.S. Food and Drug Administration to treat adults with mantle cell lymphoma.

Mantle cell is an aggressive, fast-growing non-Hodgkin lymphoma, a cancer of the lymph system. Though it represents only 3 percent to 10 percent of non-Hodgkin cases in the United States, the cancer usually has spread by the time it's detected, the FDA said in a news release on Tuesday.

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Gene Therapy Approved for B-Cell Lymphoma

THURSDAY, Oct. 19, 2017 --Yescarta (axicabtagene ciloleucel) has been approved by the U.S. Food and Drug Administration as the first form of gene therapy for a non-Hodgkin lymphoma (NHL) form of cancer.

Diffuse large B-cell lymphoma is the most common form of this immune system cancer in adults, the agency said in a news release. Some 72,000 cases of NHL are diagnosed each year in the United States, and the Diffuse large-B cell form represents about a third of these cases, the FDA added.

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Remede System Approved for Sleep Apnea

MONDAY, Oct. 9, 2017 -- The Remede sleep system, an implanted device that treats central sleep apnea by activating a nerve that sends signals to the diaphragm to stimulate breathing, has been approved by the U.S. Food and Drug Administration.

Central sleep apnea occurs when the brain fails to send signals to the diaphragm, triggering lapses in breathing that can last a few seconds to minutes, the agency said in a news release. This can lead to poor sleep and ultimately raise a person's risk of health problems such as high blood pressure, heart attack, heart failure, stroke, obesity and diabetes, the FDA said.

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First Test to Detect Zika in Blood Donations Approved

FRIDAY, Oct. 6, 2017 -- The cobas Zika test has been approved by the U.S. Food and Drug Administration -- the first approved screening test to detect the Zika virus in blood donations.

The test is not designed to diagnose any particular person's Zika infection, however, the FDA said.

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Verzenio Approved for Advanced Breast Cancer

FRIDAY, Sept. 29, 2017 -- Verzenio (abemaciclib) has been approved by the U.S. Food and Drug Administration to treat women with certain advanced forms of breast cancer, the most common cancer in the United States.

More than 250,000 women are projected to be diagnosed with breast cancer this year, and more than 40,000 will die of the disease, the U.S. National Cancer Institute estimates.

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Glucose Monitoring System Eliminates Need for Finger Pricks

THURSDAY, Sept. 28, 2017 -- The FreeStyle Flash Glucose Monitoring System has been approved by the U.S. Food and Drug Administration, making it the first sanctioned device to monitor blood sugar in adult diabetics without the need for a finger prick.

"This system allows people with diabetes to avoid the additional step of fingerstick calibration, which can sometimes be painful, but still provides necessary information for treating their diabetes," said Donald St. Pierre, acting director of the Office of In Vitro Diagnostics and Radiological Health and deputy director of new product evaluation in the FDA's Center for Devices and Radiological Health.

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