FDA Approvals

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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App to Help Treat Substance Abuse Approved

THURSDAY, Sept. 14, 2017 -- The U.S. Food and Drug Administration has approved its first mobile app to help treat substance abuse, the agency said Thursday in a news release.

The Reset application is designed to help treat abuse of alcohol, cocaine, marijuana and stimulant medications. But the app is not intended for opioid dependence, the FDA said.

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Aliqopa Approved for Follicular Lymphoma

THURSDAY, Sept. 14, 2017 -- Aliqopa (copanlisib) has been approved by the U.S. Food and Drug Administration to treat adults with relapsed follicular lymphoma who have received at least two prior treatments with certain other drugs.

Follicular lymphoma is a slow-growing cancer of the lymph system of the type known as non-Hodgkin lymphoma. More than 72,000 people in the United States are likely to be diagnosed with some form of the illness this year, and more than 20,000 will die from the disease, federal estimates project.

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Mvasi Is First Biosimilar Drug Approved for Cancer

THURSDAY, Sept. 14, 2017 -- The first biosimilar drug to treat cancer has been approved by the U.S. Food and Drug Administration.

Mvasi (bevacizumab-awwb) was found to be biosimilar to the anti-cancer drug Avastin, the FDA said Thursday in a news release. Avastin was approved in 2004.

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First Gene Therapy Approved in U.S.

WEDNESDAY, Aug. 30, 2017 -- The U.S. Food and Drug Administration on Wednesday approved the first gene therapy in the United States, to treat children and young adults with a particularly tough type of leukemia.

Kymriah (tisagenlecleucel) is for B-cell acute lymphoblastic leukemia (ALL), the agency said in a news release.

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Antibiotic Vabomere Approved

WEDNESDAY, Aug. 30, 2017 -- The intravenous antibiotic Vabomere (meropenem and vaborbactam) has been approved by the U.S. Food and Drug Administration to treat certain complicated urinary tract infections, including the kidney infection pyelonephritis.

"The FDA is committed to making new safe and effective antibacterial drugs available," said Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research. "This approval provides an additional treatment option for patients with [complicated urinary tract infection], a type of serious bacterial infection."

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Pediatric Treatment Approved for 'Kissing Bug' Disease

WEDNESDAY, Aug. 30, 2017 -- Benznidazole has been approved by the U.S. Food and Drug Administration to treat the tropical parasitic infection Chagas, or "kissing bug" disease, in children aged 2 to 12.

""The FDA is committed to making available safe and effective therapeutic options to treat tropical diseases," said Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research.

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