FDA Approvals

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."

Read more

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.

Read more

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.

Read more

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.

Read more

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.

Read more

New Treatment for Non-Hodgkin Lymphoma Approved

WEDNESDAY, Aug. 8, 2018 -- Poteligeo (mogamulizumab) injection has been approved by the U.S. Food and Drug Administration to treat adults with two types of non-Hodgkin lymphoma.

The drug was approved to treat relapsed or refractory mycosis fungoides (MF) and Sézary syndrome (SS) after the patient has had at least one prior therapy delivered through the bloodstream.

Read more

Azedra Approved for Rare Adrenal Tumors

TUESDAY, July 31, 2018 -- Azedra (iobenguane) has been approved by the U.S. Food and Drug Administration to treat people 12 and older with rare adrenal gland tumors that can't be surgically removed and have spread beyond the original site.

The adrenal glands sit above the kidneys and produce the stress hormones epinephrine and norepinephrine. The rare tumors known as pheochromocytomas spike production of these hormones, leading to possible symptoms including high blood pressure, headache, irritability, excessive sweating and rapid heartbeat. Sometimes, such tumors develop outside the adrenal gland, where they're called paragangliomas, the FDA said in a news release.

Read more

Magnetic System Approved for Guiding Lymph Biopsies

WEDNESDAY, July 25, 2018 -- A magnetic system for guiding lymph node biopsies in certain people with breast cancer has been approved by the U.S. Food and Drug Administration.

The Sentimag System uses magnetic detection during a sentinel lymph node biopsy to identify certain lymph nodes for removal, the agency said in a news release.

Read more

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.

Read more

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.

Read more

Jump to Page :