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FDA takes major step to put greater emphasis on the prevention of foodborne illness

The U.S. Food and Drug Administration today took one of the most significant steps in decades to prevent foodborne illness by finalizing the first two of seven major rules under the bipartisan FDA Food Safety Modernization Act (FSMA).

9 Oct 2015

FDA allows marketing of new EarLens Contact Hearing Device

The U.S. Food and Drug Administration today allowed marketing of a new hearing aid that uses a laser diode and direct vibration of the eardrum to amplify sound. The combination of laser light pulses and a custom-fit device component that comes in direct contact with the eardrum is designed to use the patient's own eardrum as a speaker and enables amplification over a wider range of frequencies for some hearing impaired persons.

9 Oct 2015

FDA approves Lonsurf drug for patients with advanced form of colorectal cancer

The U.S. Food and Drug Administration today approved Lonsurf (a pill that combines two drugs, trifluridine and tipiracil) for patients with an advanced form of colorectal cancer who are no longer responding to other therapies.

9 Oct 2015

Safety and immunogenicity clinical trial of Ebola vaccine regimen starts in Sierra Leone

Johnson & Johnson today announced the start of a safety and immunogenicity clinical trial in Sierra Leone of a preventive Ebola vaccine regimen in development at its Janssen Pharmaceutical Companies.

9 Oct 2015

FDA approves expanded indication for Optune device for brain cancer patients

The U.S. Food and Drug Administration today approved an expanded indication for the Optune device to treat patients with newly-diagnosed glioblastoma multiforme (GBM), an aggressive form of brain cancer.

9 Oct 2015

FDA announces launch of new education campaign to prevent, reduce tobacco use among hip-hop youth

The U.S. Food and Drug Administration today announced the launch of a national public education campaign to prevent and reduce tobacco use among multicultural youth who identify with the hip-hop peer crowd ‒ a group that is often hard to reach and frequently exposed to pro-tobacco images and messages. While multicultural teens identify with more than one group, the FDA is focusing on those in the hip-hop peer crowd because research estimates that they are more likely to use tobacco than other youth.

9 Oct 2015

Xuriden (uridine triacetate) now approved for patients with hereditary orotic aciduria

Today, the U.S. Food and Drug Administration approved Xuriden (uridine triacetate), the first FDA-approved treatment for patients with hereditary orotic aciduria. Hereditary orotic aciduria is a rare metabolic disorder, which has been reported in approximately 20 patients worldwide.

9 Oct 2015

FDA approves Promacta to treat pediatric patients with chronic immune thrombocytopenic purpura

The U.S. Food and Drug Administration today approved Promacta (eltrombopag) to treat low blood platelet count in pediatric patients – ages one year and older – with a rare blood disorder called chronic immune thrombocytopenic purpura (ITP). Promacta can be used in these children when they have not achieved an appropriate response using other ITP medicines or surgery to remove the spleen.

9 Oct 2015

Aristada (aripiprazole lauroxil) extended release injection approved to treat adults with schizophrenia

On October 5, the U.S. Food and Drug Administration approved Aristada (aripiprazole lauroxil) extended release injection to treat adults with schizophrenia. Aristada is administered by a health care professional every four to six weeks using an injection in the arm or buttocks.

9 Oct 2015

Tresiba and Ryzodeg approved to improve blood sugar control in adults with diabetes mellitus

The U.S. Food and Drug Administration today approved Tresiba (insulin degludec injection) and Ryzodeg 70/30 (insulin degludec/insulin aspart injection) to improve blood sugar (glucose) control in adults with diabetes mellitus.

9 Oct 2015

Varubi (rolapitant) approved to prevent delayed phase chemotherapy-induced nausea and vomiting

The U.S. Food and Drug Administration approved Varubi (rolapitant) to prevent delayed phase chemotherapy-induced nausea and vomiting (emesis). Varubi is approved in adults in combination with other drugs (antiemetic agents) that prevent nausea and vomiting associated with initial and repeat courses of vomit-inducing (emetogenic and highly emetogenic) cancer chemotherapy.

9 Oct 2015

Vraylar (cariprazine) capsules now approved by FDA to treat schizophrenia, bipolar disorder in adults

The U.S. Food and Drug Administration today approved Vraylar (cariprazine) capsules to treat schizophrenia and bipolar disorder in adults.

9 Oct 2015

Repatha (evolocumab) injection gets FDA approval for high cholesterol

The U.S. Food and Drug Administration today approved Repatha (evolocumab) injection for some patients who are unable to get their low-density lipoprotein (LDL) cholesterol under control with current treatment options.

9 Oct 2015

BMC awarded NIDDK grant to study outcomes of minority women receiving diabetes self-management education

The National Institute of Diabetes and Digestive and Kidney Diseases has awarded a $783,906 grant to Suzanne Mitchell, MD, a family physician at Boston Medical Center, to study health outcomes of minority women with type 2 diabetes who participate in group medical visits to help them manage their diabetes.

9 Oct 2015

NIH launches new Breast Cancer and the Environment Research Program focused on prevention

A new phase of the Breast Cancer and the Environment Research Program (BCERP), focused on prevention, is being launched at the National Institutes of Health. Grant-funded researchers will now work across scientific disciplines, involve new racially and ethnically diverse communities, and expand the study of risk factors that precede breast cancer, such as breast density.

9 Oct 2015

FDA grants accelerated approval for Keytruda to treat patients with advanced NSCLC

The U.S. Food and Drug Administration today granted accelerated approval for Keytruda (pembrolizumab) to treat patients with advanced (metastatic) non-small cell lung cancer (NSCLC) whose disease has progressed after other treatments and with tumors that express a protein called PD-L1. Keytruda is approved for use with a companion diagnostic, the PD-L1 IHC 22C3 pharmDx test, the first test designed to detect PD-L1 expression in non-small cell lung tumors.

9 Oct 2015

UGA awarded $8.2 million grant to improve lives of children and families in Georgia' child welfare system

A team of University of Georgia faculty members, led by a researcher in the College of Family and Consumer Sciences, has received an $8.2 million grant from the Administration for Children and Families, a division of the U.S. Department of Health and Human Services, to improve the lives of children and families in the child welfare system in Georgia.

7 Oct 2015

NIH researchers discover why certain immune responses can be harmful to the brain

National Institutes of Health scientists studying inflammation of the brain have discovered why certain immune responses, which typically help cells recognize and fight viral and bacterial infections, can sometimes be harmful to the brain. Many brain disorders involve the death of neurons, or nerve cells, but how these neurons die is not well understood.

7 Oct 2015

NIH-funded researchers test new gene therapy to improve visual function in mice

Researchers funded by the National Institutes of Health have developed a novel mouse model for the vision disorder Leber hereditary optic neuropathy (LHON), and found that they can use gene therapy to improve visual function in the mice. LHON is one of many diseases tied to gene mutations that damage the tiny energy factories that power our cells, called mitochondria.

6 Oct 2015

International team of scientists create world's largest catalog of genomic variations among humans

An international team of scientists from the 1000 Genomes Project Consortium has created the world's largest catalog of genomic differences among humans, providing researchers with powerful clues to help them establish why some people are susceptible to various diseases. While most differences in peoples' genomes - called variants - are harmless, some are beneficial, while others contribute to diseases and conditions, ranging from cognitive disabilities to susceptibilities to cancer, obesity, diabetes, heart disease and other disorders.

1 Oct 2015

Health and Human Services News and Research

FDA takes major step to put greater emphasis on the prevention of foodborne illness

FDA allows marketing of new EarLens Contact Hearing Device

FDA approves Lonsurf drug for patients with advanced form of colorectal cancer

Safety and immunogenicity clinical trial of Ebola vaccine regimen starts in Sierra Leone

FDA approves expanded indication for Optune device for brain cancer patients

FDA announces launch of new education campaign to prevent, reduce tobacco use among hip-hop youth

Xuriden (uridine triacetate) now approved for patients with hereditary orotic aciduria

FDA approves Promacta to treat pediatric patients with chronic immune thrombocytopenic purpura

Aristada (aripiprazole lauroxil) extended release injection approved to treat adults with schizophrenia

Tresiba and Ryzodeg approved to improve blood sugar control in adults with diabetes mellitus

Varubi (rolapitant) approved to prevent delayed phase chemotherapy-induced nausea and vomiting

Vraylar (cariprazine) capsules now approved by FDA to treat schizophrenia, bipolar disorder in adults

Repatha (evolocumab) injection gets FDA approval for high cholesterol

BMC awarded NIDDK grant to study outcomes of minority women receiving diabetes self-management education

NIH launches new Breast Cancer and the Environment Research Program focused on prevention

FDA grants accelerated approval for Keytruda to treat patients with advanced NSCLC

UGA awarded $8.2 million grant to improve lives of children and families in Georgia' child welfare system

NIH researchers discover why certain immune responses can be harmful to the brain

NIH-funded researchers test new gene therapy to improve visual function in mice

International team of scientists create world's largest catalog of genomic variations among humans

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