FDA Approvals

First Auto-Darken Contact Lenses Approved

TUESDAY, April 10, 2018 -- The U.S. Food and Drug Administration has approved the first contact lenses that automatically darken in bright light, the agency said Tuesday in a news release.

The technology, used for years in eyeglasses, stems from an additive that's added to the lenses, which then react to the sun's ultraviolet rays. The Acuvue Oasys lenses return to their normal tint when the user moves to normal or darker lighting.

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Blincyto Approval Expanded for Specific Leukemia

THURSDAY, March 29, 2018 -- The U.S. Food and Drug Administration says it has expanded approval for Blincyto (blinatumomab) to include adults and children with B-cell precursor acute lymphoblastic leukemia who are in remission but who still have minimal residual disease (MRD).

MRD describes the presence of cancer cells in the body, but below levels that can be seen in a microscope, the agency said Thursday in a news release. This condition raises a person's chances that the cancer will come back.

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Adcetris Approval Expanded to Include Later-Stage Hodgkin Lymphoma

TUESDAY, March 20, 2018 -- U.S. Food and Drug Administration approval of Adcetris (brentuximab vedotin) has been expanded to include adults with untreated stage III or IV classical Hodgkin lymphoma, the agency said Tuesday in a news release.

The drug was first approved to treat Hodgkin lymphoma in 2011 and has been granted a number of additional approvals.

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First Screening Tests Approved for Tickborne Parasite

WEDNESDAY, March 7, 2018 -- The first set of blood screening tests for the tickborne parasite Babesia microti have been approved by the U.S. Food and Drug Administration.

Also dubbed B. microti, the parasite infects 1,000 to 2,000 people per year in the United States, the agency said in a news release. In addition to being carried by blacklegged or deer ticks, the disease also can be transmitted via the blood, organs or tissue of an infected donor.

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New Medication Approved for Drug-Resistant HIV

TUESDAY, March 6, 2018 -- Trogarzo (ibalizumab-uiyk) has been approved by the U.S. Food and Drug Administration to treat AIDS-causing HIV that has not responded to other antiretroviral medications.

Trogarzo is given intravenously once every 14 days in combination with other antiretroviral drugs, the FDA said Tuesday in a news release.

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Mechanical Heart Valve Approved for Newborns

TUESDAY, March 6, 2018 -- The U.S. Food and Drug Administration has approved the world's smallest mechanical heart valve, designed to be used in newborns and other younger infants with heart defects.

In a news release Tuesday, the agency said it approved a 15 mm version of the Masters Series Mechanical Heart Valve with Hemodynamic Plus Sewing Cuff.

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First Blood Test to Evaluate Potential Concussions Approved

WEDNESDAY, Feb. 14, 2018 -- The first blood test designed to help doctors evaluate whether a suspected brain injury is a concussion has been approved by the U.S. Food and Drug Administration.

Traditional concussion evaluation includes a CT scan of the head to detect any brain tissue damage. But many people who have such a scan do not have brain lesions that are detectable, the FDA said Wednesday in a news release.

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New Treatment Approved for Prostate Cancer That Resists Hormone Therapy

WEDNESDAY, Feb. 14, 2018 -- Erleada (apalutamide) has been approved by the U.S. Food and Drug Administration to treat non-spreading prostate cancer that continues to grow despite hormone therapy.

Prostate cancer is the second-most-common form of the disease among men in the United States, the National Cancer Institute says. More than 161,000 men were diagnosed in 2017, and nearly 27,000 men were projected to die of prostate cancer last year, the NCI estimates.

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Lutathera Approved for Some Gastro and Pancreatic Cancers

FRIDAY, Jan. 26, 2018 -- Lutathera (lutetium Lu 177 dotatate) is the first radioactive drug to be approved by the U.S. Food and Drug Administration to treat certain cancers of the gastrointestinal tract and pancreas, the agency said Friday in a news release.

About 1 in 27,000 people is diagnosed annually with this type of cancer, called gastroenteropancreatic neuroendocrine tumors (GEP-NETs). In addition to the pancreas, the cancer also may emerge in the stomach, intestines, colon and rectum, the FDA said.

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First Treatment Approved for Breast Cancer Caused by Specific Gene Mutation

FRIDAY, Jan. 12, 2018 -- Lynparza (olaparib) has been approved by the U.S. Food and Drug Administration to treat spreading breast cancer caused by a BRCA gene mutation.

The drug is among a class called poly ADP-ribose polymerase (PARP) inhibitors, which are designed to block an enzyme involved in repairing damaged DNA. The hope is that by blocking the repair of cancer cells, the cells will die and slow or stop tumor growth, the FDA said in a news release Friday.

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