FDA Approvals

Nerlynx Approved to Help Prevent Breast Cancer's Return

TUESDAY, July 18, 2017 -- Nerlynx (neratinib) has been approved by the U.S. Food and Drug Administration to help prevent HER2-positive breast cancer from returning.

It's the first drug designed to prevent return of HER2-positive breast cancer, a genetic form of the disease that's particularly aggressive and can spread to other parts of the body, the agency said in a news release.

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New Drug Approved for All Cancers With Genetic Marker

TUESDAY, May 23, 2017 -- Keytruda (pembrolizumab) has been approved by the U.S. Food and Drug Administration to treat any cancer that has a certain genetic biomarker, regardless of where in the body the cancer originated.

"This is an important first for the cancer community," said Dr. Richard Pazdur, acting director of the agency's Office of Hematology and Oncology Products. "Until now, the FDA has approved cancer treatments based on where in the body the cancer started, for example lung or breast cancers. We have now approved a drug based on a tumor's biomarker without regard to the tumor's original location."

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Actemra Approved for Certain Blood Vessel Inflammation

MONDAY, May 22, 2017 -- The injected drug Actemra (tocilizumab) has been approved by the U.S. Food and Drug Administration to treat adults with giant cell arteritis, an inflammation of the blood vessels (vasculitis).

In a media release Monday, the FDA said this form of vasculitis mostly involves blood vessels of the head. Traditional therapy includes large doses of anti-inflammatory drugs called corticosteroids.

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Kalydeco Approval Widened for More Types of Cystic Fibrosis

THURSDAY, May 18, 2017 -- The U.S. Food and Drug Administration says it has expanded approval for the cystic fibrosis drug Kalydeco (ivacaftor) to include 33 mutations of the disease, up from the previous 10 mutations.

In a media release, the agency said its decision was based on results of laboratory testing and previous clinical trials.

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New Device Approved for Esophageal Birth Defect

MONDAY, May 15, 2017 -- A new medical device has been approved by the U.S. Food and Drug Administration to treat esophageal atresia, a birth defect that causes a gap between the esophagus and stomach.

One of 2,500 babies in the United States is born with the condition, the agency said in a news release. These infants require a feeding tube until surgery is performed to connect the esophagus to the stomach.

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Brineura Approved for Rare Genetic Illness Affecting Kids

FRIDAY, April 28, 2017 -- Brineura (cerliponase alfa) has been approved by the U.S. Food and Drug Administration to treat a specific form of Batten Disease, a rare set of genetic disorders that typically begin in childhood between ages 2 and 4, the agency said in a news release.

Initial symptoms of the CLN2 form of Batten, for which the drug is approved, usually include language delay, seizures and coordination problems. Affected children also develop vision loss and motor-skill issues, including trouble walking. Many require a wheelchair by late childhood and often don't survive past their teens, the agency said.

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Rydapt Approved for Adults With Acute Myeloid Leukemia

FRIDAY, April 28, 2017 -- Rydapt (midostaurin) has been approved by the U.S. Food and Drug Administration, in combination with chemotherapy, to treat adults with acute myeloid leukemia (AML) who have a specific genetic mutation dubbed FLT3.

AML, a rapidly spreading cancer that forms in the blood marrow and spikes white blood cells, is projected to be diagnosed in just under 20,000 people, and more than 10,000 are expected to die of the disease annually, the FDA said.

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Stivarga Approved for Liver Cancer

THURSDAY, April 27, 2017 -- U.S. Food and Drug Administration approval of the anti-cancer drug Stivarga (regorafenib) has been expanded to include liver cancer, the agency said Thursday in a news release.

Stivarga, among a class of drugs called kinase inhibitors, is designed to block enzymes that foster cancer growth. It's the first drug approved to treat liver cancer in nearly a decade, the FDA said.

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1st Drug for Tardive Dyskinesia Approved

WEDNESDAY, April 12, 2017 -- Ingrezza (valbenazine), the first drug to treat adults with the neurological disorder tardive dyskinesia, has been approved by the U.S. Food and Drug Administration.

The disorder is characterized by repetitive involuntary movements, usually of the jaw, lips and tongue. Affected people may stick out the tongue, smack the lips, involuntarily move the arms and legs, and have trouble breathing, the FDA said in a news release.

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FDA Approves Hep C Drugs for Kids 12 and Older

FRIDAY, April 7, 2017 -- The U.S. Food and Drug Administration has approved two drugs to treat hepatitis C infection in children aged 12 and older.

Both Solvaldi (sofosbuvir) and Harvoni (ledipasvir, sofosbuvir) are already approved for use in adults, the agency said in a news release Friday.

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