FDA Approvals

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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New Treatment Approved for Deadly Blood Cancer

THURSDAY, Aug. 17, 2017 -- The U.S. Food and Drug Adminstration on Thursday approved the anti-cancer drug Besponsa (inotuzumab ozogamicin) to treat B-cell acute lymphoblastic leukemia (ALL).

B-cell ALL is a rapidly growing cancer that occurs when the bone marrow makes too many B-cell lymphocytes, a type of white blood cell. Almost 6,000 people in the United States are likely to be diagnosed with the disease this year, and more than 1,400 are projected to die from it, according to estimates from the U.S. National Cancer Institute.

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New Treatment Approved for Acute Myeloid Leukemia

THURSDAY, Aug. 3, 2017 -- The combination chemotherapy drug Vyxeos (daunorubicin and cytarabine) has been approved by the U.S. Food and Drug Administration as the first treatment for certain high-risk types of acute myeloid leukemia (AML).

AML is an aggressive blood cancer that forms in the bone marrow.

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Imbruvica Approval Expanded to Include Graft Versus Host Disease

WEDNESDAY, Aug. 2, 2017 -- The U.S. Food and Drug Administration on Wednesday expanded approval for the anti-cancer drug Imbruvica (ibrutinib) to include adults with chronic graft versus host disease (cGVHD).

cGVHD is a deadly condition that affects up to 70 percent of people who receive a stem cell transplant to treat cancers of the blood or bone marrow, the FDA said in a news release. The condition occurs when the transplanted cells attack healthy cells in a patient's tissues.

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Idhifa Approved for Some With Acute Myeloid Leukemia

TUESDAY, Aug. 1, 2017 -- Idhifa (enasidenib) has been approved by the U.S. Food and Drug Administration to treat adults with a specific genetic mutation that leads to relapsed or refractory acute myeloid leukemia (AML).

The mutation in the IDH2 gene can be diagnosed with a newly approved companion diagnostic, the RealTime IDH2 Assay, the agency said in a news release Tuesday.

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