FDA Approvals

New DNA-Based Test Approved to Help Verify Blood Compatibility

FRIDAY, Oct. 12, 2018 -- The U.S. Food and Drug Administration has approved the ID CORE XT DNA-based test to help doctors verify blood compatibility before a transfusion.

People who need repeated transfusions, such as those with sickle cell disease, are more likely to develop certain antibodies. If blood with poorly-matched antibodies is transfused, the procedure is more likely to lead to red-blood-cell destruction and a transfusion reaction, the agency explained.

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HPV Vaccine Approved for People Through Age 45

TUESDAY, Oct. 9, 2018 -- U.S. Food and Drug Administration approval of the Gardasil 9 human papillomavirus (HPV) vaccine has been expanded to include people ages 27 through 45, the agency said in a news release.

Gardasil 9, approved in 2014 for people ages 9 through 26, is the follow-up vaccine to the original Gardasil, which was approved in 2006 and is no longer sold in the United States. The updated vaccine is designed to prevent cancers and disease caused by nine HPV types.

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First User-Fitted Hearing Aid Approved

FRIDAY, Oct. 5, 2018 -- The first hearing aid that doesn't require the assistance of an audiologist or other health care provider has been approved by the U.S. Food and Drug Administration.

The Bose Hearing Aid is a user-fitted device for people aged 18 and older with mild-to-moderate hearing loss, the agency said Friday in a news release.

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New Treatment Approved for Common Skin Cancer

MONDAY, Oct. 1, 2018 -- Libtayo (cemiplimab-rwlc) injection has been approved by the U.S. Food and Drug Administration to treat advanced squamous cell carcinoma (CSCC), the agency said in a news release.

The drug is from a class of medications called immune checkpoint inhibitors. These drugs target a protein found on the body's immune cells and certain cancer cells called PD-1, the FDA explained. Libtayo is designed to help the body's immune system fight the cancer.

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New Drug Approved for Antibiotic-Resistant Lung Disease

MONDAY, Oct. 1, 2018 -- Arikayce has been approved by the U.S. Food and Drug Administration to treat lung disease caused by Mycobacterium avium complex (MAC) bacteria among people who don't respond to conventional therapies, the FDA said in a news release.

MAC bacteria are commonly found in water and soil. Symptoms of MAC-triggered lung disease include chronic cough, fatigue, weight loss, night sweats and possibly shortness of breath and coughing up blood, the FDA said.

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New Device Approved for Tears in Heart's Blood Vessels

FRIDAY, Sept. 14, 2018 -- The PK Papyrus Covered Coronary Stent System has been approved by the U.S. Food and Drug Administration to treat acute coronary artery perforations, the medical term for tears in the heart's blood vessels.

"An acute coronary artery perforation is a rare, but potentially life-threatening complication of heart vessel [surgery]," Dr. Bram Zuckerman, director of the FDA's Division of Cardiovascular Devices, said Friday in an agency news release. "The [device] provides health care providers with a new treatment option that can seal the perforation in order to stop blood leakage during the procedure."

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Novel Treatment Approved for 'Hairy Cell' Leukemia

THURSDAY, Sept. 13, 2018 -- Lumoxiti injection has been approved to treat certain instances of relapsed or refractory "hairy cell" leukemia (HCL), the U.S. Food and Drug Administration said Thursday.

Lumoxiti (moxetumomab pasudotox-tdfk) is among a novel class of drugs called CD22-directed cytotoxins to treat HCL, the agency said. It was approved for adults who have had at least two prior therapies for the disease.

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New Treatment Approved for Opioid Dependence

MONDAY, Sept. 10, 2018 -- Cassipa (buprenorphine and naloxone), a film designed to be placed under the tongue, has been approved to treat opioid dependence, the agency said in a news release.

Both buprenorphine and naloxone have been approved previously for this purpose.

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First Drug Approved for Rare Eye Disease

THURSDAY, Aug. 23, 2018 -- Oxervate (cenegermin) has been approved by the U.S. Food and Drug Administration to treat neurotrophic keratitis, a rare disease of the eye's cornea.

The cornea is the clear layer that covers the colored portion at the front of the eye.

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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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