FDA approves new treatment for a certain type of prostate cancer using novel clinical trial endpoint
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- Written by IVN
- Category: Health News
Washington, DC - The U.S. Food and Drug Administration approved Erleada (apalutamide) for the treatment of patients with prostate cancer that has not spread (non-metastatic), but that continues to grow despite treatment with hormone therapy (castration-resistant). This is the first FDA-approved treatment for non-metastatic, castration-resistant prostate cancer.
FDA authorizes marketing of first blood test to aid in the evaluation of concussion in adults
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- Written by IVN
- Category: Health News
Washington, DC - The U.S. Food and Drug Administration today permitted marketing of the first blood test to evaluate mild traumatic brain injury (mTBI), commonly referred to as concussion, in adults. The FDA reviewed and authorized for marketing the Banyan Brain Trauma Indicator in fewer than 6 months as part of its Breakthrough Devices Program.
Get a flu shot, now - there is still time
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- Written by John Grimaldi
- Category: Health News
Washington, DC - Senior citizen advocate Dan Weber has issued a call for the elderly, in particular, to get a flu shot if they haven't done so already. He says it is not too late. The flu season began earlier than usual this year and is expected to last for months.
New steps to facilitate efficient generic drug review to enhance competition, promote access and lower drug prices
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- Written by IVN
- Category: Health News
Washington, DC - The FDA announced additional steps to encourage generic competition as part of our continued implementation of the Drug Competition Action Plan. This plan has three main components: reducing gaming by branded companies that can delay generic drug entry; resolving scientific and regulatory obstacles that can make it difficult to win approval of generic versions of certain complex drugs; and improving the efficiency and predictability of the FDA’s generic review process to reduce the time it takes to get a new generic drug approved and lessen the number of review cycles undergone by generic applications before they can be approved.
Hempler Foods Group, LLC Recalls Pepperoni Products due to Possible Extraneous Material Contamination
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- Written by USDA
- Category: Health News
Washington, DC - Hempler Foods Group, LLC, a Ferndale, Washington establishment, is recalling approximately 4,068 pounds of pepperoni sticks products that may be contaminated with extraneous material, specifically metal, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
New Cancer Drug Approvals From 2017
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- Written by American Cancer Society
- Category: Health News
Atlanta, Georgia - Chemotherapy is one of the most powerful tools we have to treat cancer, and research continues to find new chemotherapy drugs as well as new uses for existing ones. At the same time, newer types of drugs are being developed that work in different ways to attack cancer cells. These types of drugs include targeted therapy, which aims to more precisely identify cancer cells while doing less damage to normal cells, and immunotherapy, which uses the body’s own immune system to help find and destroy cancer. This year, the US Food and Drug Administration (FDA) granted its first approvals for a type of immune therapy – or gene modification therapy – that changes a patient’s own T cells in the lab to make them more effective against cancer.
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