FDA Approvals

Tibsovo Approved for Acute Myeloid Leukemia

FRIDAY, July 20, 2018 -- Tibsovo (ivosidenib) tablets have been approved by the U.S. Food and Drug Administration to treat relapsed or refractory acute myeloid leukemia (AML) among people with a defective IDH1 gene.

"The use of Tibsovo is associated with a complete remission in some patients and a reduction in the need for both red cell and platelet transfusions," said Dr. Richard Pazdur, director of the FDA's Oncology Center of Excellence.

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First Drug to Treat Smallpox Approved

MONDAY, July 16, 2018 -- TPOXX (tecovirimat) has been approved by the U.S. Food and Drug Administration to treat smallpox.

Though the contagious and often-deadly viral disease was considered eradicated by the World Health Organization in 1980, there are concerns that smallpox could be used in a terrorist attack.

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1st 'Biosimilar' OK'd to Prevent Chemo-Related Infections

TUESDAY, June 5, 2018 -- The first "biosimilar" drug to Neulasta, designed to ward off infections related to chemotherapy, has been approved by the U.S. Food and Drug Administration.

Fulphila (pegfilgrastim) is approved for people with symptoms of febrile neutropenia, which is characterized by fever and other signs of infection such as low white-blood-cell count, the FDA said in a news release. People receiving immune-system suppressing chemotherapy for non-bone marrow cancer are at heightened risk for febrile neutropenia, the agency added.

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New Treatment for Ulcerative Colitis Approved

WEDNESDAY, May 30, 2018 -- U.S. Food and Drug Administration approval of Xeljanz (tofacitinib) has been expanded to include adults with active moderate-to-severe ulcerative colitis, the agency said Wednesday.

Ulcerative colitis (UC) is a chronic inflammatory bowel disease, characterized by recurring flares of abdominal pain and bloody diarrhea. Symptoms also may include fatigue, weight loss and fever.

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First Artificial Iris is Approved

WEDNESDAY, May 30, 2018 -- The first artificial iris to replace the colored section of the eye that surrounds the pupil has been approved by the U.S. Food and Drug Administration.

Many people who are candidates for the device were born with a condition called aniridia, a rare genetic disorder in which the iris is missing or damaged. The condition affects 1 in 50,000 to 100,000 people in the United States, the FDA said Wednesday in a news release.

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New Treatment Approved for Rare Disease PKU

FRIDAY, May 25, 2018 -- Palynziq (pegvaliase-pqpz) has been approved by the U.S. Food and Drug Administration to treat phenylketonuria, commonly called PKU.

People with the rare yet serious inherited disorder can't break down an amino acid called phenylalanine, which is found in many sweeteners and protein-containing foods.

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Doptelet Approved for Liver Disease Patients Slated for a Medical Procedure

MONDAY, May 21, 2018 -- Doptelet (avatrombopag) has been approved by the U.S. Food and Drug Administration to treat adults with chronic liver disease who are slated to have a medical or dental procedure.

People with ongoing liver disease often have low blood platelet count, which raises their risk for dangerous bleeding during a medical procedure, the agency said Monday in a news release.

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Aimovig Approved to Prevent Migraines

FRIDAY, May 18, 2018 -- Aimovig (erenumab-aooe) has been approved by the U.S. Food and Drug Administration to prevent migraine headaches in adults.

Aimovig is the first FDA-approved preventive migraine treatment in a new class of drugs that work by blocking the activity of calcitonin gene-related peptide, a molecule involved in migraine attacks, the agency said in a news release.

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Non-Opioid Treatment Approved for Opioid Withdrawal

THURSDAY, May 17, 2018 -- Lucemyra (lofexidine hydrochloride) has been approved by the U.S. Food and Drug Administration to treat symptoms of opioid withdrawal.

Withdrawal from an opioid painkiller can trigger symptoms including anxiety, agitation, sleep problems, muscle aches, sweating, nausea, diarrhea and drug craving. To prevent such symptoms, doctors typically recommend slow withdrawal from the drug, the FDA said.

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'BioSimilar' Drug Approved to Treat Certain Types of Anemia

TUESDAY, May 15, 2018 -- Retacrit (epoetin alfa-epbx) has been approved by the U.S. Food and Drug Administration as the first "biosimilar" to the anemia drugs Epogen and Procrit.

A biosimilar, derived from a living organism, has been proven to be "highly similar" to a product that's already been approved by the FDA. It's also been shown to have no "clinically meaningful differences" in its safety, purity and potency than the prior approved drugs, the agency explained Tuesday in a news release.

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