Tag: FDA
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FDA Approves Four-Times-Per-Year Schizophrenia Drug
19 May 2015. Food and Drug Administration approved for sale in the U.S. a drug for controlling schizophrenia symptoms that individuals need to take only four times per year. Janssen Pharmaceuticals, a division of Johnson & Johnson, markets the three-month version of the drug paliperidone palmitate under the brand name Invega Trinza. Schizophrenia is a…
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Standard Devised to Cut Poultry Antibiotic Use
7 May 2015. An organization of school districts in the U.S., joined by the Pew Charitable Trusts and U.S. Department of Agriculture, wrote a set of guidelines to reduce the use of antibiotics in raising chickens destined for school feeding programs. Tyson Foods, the nation’s largest producer of chickens, also revealed today it is adopting…
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Alzheimer’s Drug Granted Orphan Status for Fragile X
9 April 2015. A new treatment in development for Alzheimer’s disease was designated an orphan drug for Fragile X syndrome, an inherited neurological disorder, by the U.S. Food and Drug Administration. Neurotrope BioScience Inc. in Newark, New Jersey, received the designation for its drug bryostatin, now in clinical testing to treat Alzheimer’s disease. Fragile X…
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FDA Approves Inhalational Anthrax Treatment
25 March 2015. The U.S. Food and Drug Administration today approved a treatment for inhalational anthrax, a rare but dangerous respiratory condition that can result from a bioterrorist attack. The drug is marketed as Anthrasil by Emergent BioSolutions Inc. in Gaithersburg, Maryland. Anthrax is caused by Bacillus anthracis, bacteria found naturally in soil and commonly…
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Second-Hand E-Cigarette Emissions Pose Health Risks
12 March 2015. Exhaled particles from electronic cigarette smokers contain nicotine and other chemicals that could pose health risks to non-smokers in the same room, according to new research. The study, by RTI International, a research institute in North Carolina, aims to provide more health information about the largely unregulated and growing e-cigarette market. E-cigarettes…
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FDA Approves Antibody for Childhood Nerve Cell Cancer
10 March 2015. The U.S. Food and Drug Administration approved today dinutuximab, an engineered antibody to treat neuroblastoma, a rare cancer affecting nerve cells in young children. Dinutuximab is developed by United Therapeutics, a biotechnology company in Silver Spring, Maryland and marketed under the brand name Unituxin. Neuroblastoma is a cancer that develops from immature…
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Heart-on-Chip Device Built to Screen Drugs
9 March 2015. A bioengineering team at University of California in Berkeley developed a device with cardiac tissue derived from stem cells that can test drug candidates for potentially toxic effects. Researchers from the lab of engineering professor Kevin Healy published their findings today in the journal Scientific Reports. Healy and colleagues created this device…
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Registry to Track Psoriasis Drug Safety
26 February 2015. A new registry of patients with psoriasis will track the safety of a recently approved biologic drug designed to treat that disorder. The Corrona Psoriasis Registry is a joint undertaking of National Psoriasis Foundation and Corrona LLC, a company in Southborough, Massachusetts hosting registries of patients with chronic diseases. Psoriasis is an…
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New Medical Device Surveillance System Proposed
23 February 2015. A report today by a Washington, D.C. think tank proposes a new system for tracking medical devices after going on the market, to better serve patients and encourage innovation in the field. A conference at Brookings Institution that published the report highlighted many of the benefits, but also difficulties the proposed system…
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FDA Allows 23andMe to Resume Genetic Health Tests
20 February 2015. The U.S. Food and Drug Administration authorized the personal genetics company 23andMe to begin marketing genetic tests for carrying the gene causing Bloom syndrome, a serious inherited disorder. FDA also yesterday began classifying gene-carrier screening tests as class-2 medical devices requiring a limited degree of regulation, and exempting the tests from pre-market…