FDA Approvals

Ozempic Approved for Type 2 Diabetes

WEDNESDAY, Dec. 6, 2017 -- Ozempic (semaglutide) has been approved by the U.S. Food and Drug Administration as a weekly injection to treat type 2 diabetes in adults.

More than 28 million people in the United States have type 2 diabetes, which occurs when the body can no longer produce the sugar-regulating hormone insulin, or the body can't use insulin properly.

Read more

FDA Approves 'Biosimilar' Drug Ogivri for Breast, Stomach Cancers

FRIDAY, Dec. 1, 2017 -- Ogivri (trastuzumab-dkst) has been approved by the U.S. Food and Drug Administration as the nation's first biosimilar drug to treat certain breast and stomach cancers, the agency said Friday in a news release.

The maker of a biosimilar, derived from a living organism, must demonstrate that the new product is "highly similar" to an already approved medication, and that it has no clinically significant difference in terms of its potency, safety and purity, the FDA said.

Read more

Once-Monthly Injection Approved for Opioid Addiction

FRIDAY, Dec. 1, 2017 -- Sublocade, a once-monthly injection of buprenorphine to treat opioid use disorder, has been approved by the U.S. Food and Drug Administration.

Opioid abuse is diagnosed when a person's pattern of opioid use leads to "significant impairment or distress and includes signs and symptoms that reflect compulsive, prolonged self-administration of opioid substances for no legitimate medical purpose," or opioids are taken in far higher-than-recommended doses, the agency said in a news release.

Read more

New Hemophilia Treatment Stems Bleeding Episodes

THURSDAY, Nov. 16, 2017 -- Hemlibra (emicizumab-kxwh) has been approved by the U.S. Food and Drug Administration to prevent or reduce the number of bleeding episodes among certain people with hemophilia A.

The injected drug was approved for patients with antibodies called Factor VIII inhibitors. People with hemophilia A are missing a gene that produces Factor VIII, a blood-clotting protein.

Read more

Mepsevii Approved for Rare Enzyme Disorder

WEDNESDAY, Nov. 15, 2017 -- Mepsevii (vestronidase alfa-vjbk) has been approved by the U.S. Food and Drug Administration to treat a rare, genetic disorder called mucopolysaccharidosis type VII, sometimes called Sly syndrome.

Affecting fewer than 150 people worldwide, the extremely rare disorder typically causes various skeletal abnormalities that worsen with age, including short stature. Life expectancy and symptoms and vary widely, but also may include heart valve problems, enlarged liver and narrowed respiratory airways, the agency said Wednesday in a news release.

Read more

'Digital Pill' Tells Doctor When Patient Takes It

TUESDAY, Nov. 14, 2017 -- The first drug designed to alert a doctor when a patient takes the medication has been approved by the U.S. Food and Drug Administration.

Abilify MyCite (aripiprazole with sensor) has an embedded sensor that sends a message to a wearable patch that the medication's been taken. This allows the patient and doctor to track the medication's use via smartphone.

Read more

Zelboraf Approved for Rare Blood Cancer

MONDAY, Nov. 6, 2017 -- Zelboraf (vemurafenib) has been approved by the U.S. Food and Drug Administration as the first drug to treat Erdheim-Chester Disease, a rare but deadly blood cancer. The approval covers patients who have a genetic mutation called BRAF V600.

Erdheim-Chester Disease is a slow-growing cancer that originates in bone marrow, causing a spike in a type of white blood cell called a histiocyte. This can spur tumors that develop in the heart, lung, brain and elsewhere, the FDA said Monday in a news release. The cancer only affects about 700 people worldwide, about half of whom have the BRAF V600 mutation.

Read more

Calquence Approved for Mantle Cell Lymphoma

TUESDAY, Oct. 31, 2017 -- Calquence (acalabrutinib) has been approved by the U.S. Food and Drug Administration to treat adults with mantle cell lymphoma.

Mantle cell is an aggressive, fast-growing non-Hodgkin lymphoma, a cancer of the lymph system. Though it represents only 3 percent to 10 percent of non-Hodgkin cases in the United States, the cancer usually has spread by the time it's detected, the FDA said in a news release on Tuesday.

Read more

Gene Therapy Approved for B-Cell Lymphoma

THURSDAY, Oct. 19, 2017 --Yescarta (axicabtagene ciloleucel) has been approved by the U.S. Food and Drug Administration as the first form of gene therapy for a non-Hodgkin lymphoma (NHL) form of cancer.

Diffuse large B-cell lymphoma is the most common form of this immune system cancer in adults, the agency said in a news release. Some 72,000 cases of NHL are diagnosed each year in the United States, and the Diffuse large-B cell form represents about a third of these cases, the FDA added.

Read more

Remede System Approved for Sleep Apnea

MONDAY, Oct. 9, 2017 -- The Remede sleep system, an implanted device that treats central sleep apnea by activating a nerve that sends signals to the diaphragm to stimulate breathing, has been approved by the U.S. Food and Drug Administration.

Central sleep apnea occurs when the brain fails to send signals to the diaphragm, triggering lapses in breathing that can last a few seconds to minutes, the agency said in a news release. This can lead to poor sleep and ultimately raise a person's risk of health problems such as high blood pressure, heart attack, heart failure, stroke, obesity and diabetes, the FDA said.

Read more

Jump to Page :