FDA Approvals

Firdapse Approved for Rare Autoimmune Disorder

THURSDAY, Nov. 29, 2018 -- Firdapse (amifampridine) tablets have been approved by the U.S. Food and Drug Administration for adults with Lambert-Eaton myasthenic syndrome (LEMS).

It's the first agency-sanctioned treatment for the autoimmune disease that affects the connections between nerves and muscles.

Read more

Truxima Approved as First Biosimilar to Non-Hodgkin's Lymphoma Drug

WEDNESDAY, Nov. 28, 2018 -- Truxima (rituximab-abbs) has been approved by the U.S. Food and Drug Administration as the first biosimilar to the non-Hodgkin's lymphoma drug Rituxan, the agency said Wednesday.

A biosimilar is a biological product that is approved based on data showing it is "highly similar" to a drug already approved by the FDA, with no "clinically meaningful differences in terms of safety, purity and potency," the agency said in a news release.

Read more

Vitrakvi Approved for Cancers With Certain Genetic Trait

TUESDAY, Nov. 27, 2018 -- Vitrakvi (larotrectinib) has been approved by the U.S. Food and Drug Administration to treat cancers with a specific inherited trait called a biomarker.

The approval marks the second drug sanctioned to treat any type of cancer with a certain genetic feature, rather than the drug targeting a cancer that originated in a specific part of the body, the agency said in a news release.

Read more

New Ebola Test Produces Results in Remote Areas

FRIDAY, Nov. 9, 2018 -- The U.S. Food and Drug Administration has approved emergency use of a new Ebola fingerstick test, which includes a reader that makes it possible to obtain results outside a laboratory.

The DPP Ebola Antigen System makes obtaining test results possible in remote areas with limited lab resources, such as those in African nations affected by Ebola outbreaks, the agency said Friday in a news release.

Read more

New DNA-Based Test Approved to Help Verify Blood Compatibility

FRIDAY, Oct. 12, 2018 -- The U.S. Food and Drug Administration has approved the ID CORE XT DNA-based test to help doctors verify blood compatibility before a transfusion.

People who need repeated transfusions, such as those with sickle cell disease, are more likely to develop certain antibodies. If blood with poorly-matched antibodies is transfused, the procedure is more likely to lead to red-blood-cell destruction and a transfusion reaction, the agency explained.

Read more

HPV Vaccine Approved for People Through Age 45

TUESDAY, Oct. 9, 2018 -- U.S. Food and Drug Administration approval of the Gardasil 9 human papillomavirus (HPV) vaccine has been expanded to include people ages 27 through 45, the agency said in a news release.

Gardasil 9, approved in 2014 for people ages 9 through 26, is the follow-up vaccine to the original Gardasil, which was approved in 2006 and is no longer sold in the United States. The updated vaccine is designed to prevent cancers and disease caused by nine HPV types.

Read more

First User-Fitted Hearing Aid Approved

FRIDAY, Oct. 5, 2018 -- The first hearing aid that doesn't require the assistance of an audiologist or other health care provider has been approved by the U.S. Food and Drug Administration.

The Bose Hearing Aid is a user-fitted device for people aged 18 and older with mild-to-moderate hearing loss, the agency said Friday in a news release.

Read more

New Treatment Approved for Common Skin Cancer

MONDAY, Oct. 1, 2018 -- Libtayo (cemiplimab-rwlc) injection has been approved by the U.S. Food and Drug Administration to treat advanced squamous cell carcinoma (CSCC), the agency said in a news release.

The drug is from a class of medications called immune checkpoint inhibitors. These drugs target a protein found on the body's immune cells and certain cancer cells called PD-1, the FDA explained. Libtayo is designed to help the body's immune system fight the cancer.

Read more

New Drug Approved for Antibiotic-Resistant Lung Disease

MONDAY, Oct. 1, 2018 -- Arikayce has been approved by the U.S. Food and Drug Administration to treat lung disease caused by Mycobacterium avium complex (MAC) bacteria among people who don't respond to conventional therapies, the FDA said in a news release.

MAC bacteria are commonly found in water and soil. Symptoms of MAC-triggered lung disease include chronic cough, fatigue, weight loss, night sweats and possibly shortness of breath and coughing up blood, the FDA said.

Read more

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

Jump to Page :