Thursday 24 July 2014
 
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FDA

FDA approves GSK's Tanzeum for diabetes

The US Food and Drug Administration approved GlaxoSmithKline's Tanzeum injection for treating adults with type 2 diabetes, in combination with diet and exercise. Tanzeum will carry a warning on its label that tumors of the thy

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FDA approves oral drug for psoriatic arthritis

Celgene Corporation said the US Food and Drug Administration (FDA) has approved Otezla (apremilast), the company’s oral, selective inhibitor of phosphodiesterase 4 (PDE4), for the treatment of adult patients with active psoriatic arthrit

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Unease in US over Indian drug quality

Some US doctors are becoming concerned about the quality of generic drugs supplied by Indian manufacturers following a flurry of recalls and import bans by the Food and Drug Administration. India supplies about 40 percent of gener

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Move to ban trans fats in processed foods

The US Food and Drug Administration has proposed banning artificial trans fats in processed food ranging from cookies to frozen pizza, citing the risk of heart disease. Partially hydrogenated oils, the primary dietary source of th

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Roche breast cancer drug gets FDA approval

US health regulators expanded the approval of Roche Holding's breast cancer drug Perjeta and will now allow its use to help shrink tumors prior to surgery, the Food and Drug Administration said on Monday. The decision followed

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FDA strengthens hepatitis B warning on cancer drugs

US health regulators have strengthened the warnings on two blood cancer drugs to reflect the risk that they may reactivate the hepatitis B virus in patients previously infected with the disease. The warnings affect GlaxoSmithKline

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US FDA issues final rules on mobile medical apps

The US Food and Drug Administration has issued final rules governing the development of mobile medical apps, saying it will focus its oversight on those products that have the potential to harm consumers if they do not function properly.

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US FDA grants emergency nod for MERS test

The US Food and Drug Administration issued an emergency authorization on Tuesday for a diagnostic test to detect the presence of the Middle East coronavirus at the request of the Centers for Disease Control and Prevention. The eme

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Cancer drugs proving worth earlier in testing

Michael Weitz was out of options. The Californian had endured chemotherapy, radiation and surgery but his lung cancer still spread to his bones and brain. With time running out, the emergency room physician entered a Phase I study

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Roche drug for late-stage breast cancer approved

  US health regulators approved a new drug made by Swiss drugmaker Roche Holding AG for some patients with late-stage metastatic breast cancer who fail to respond to other therapies.   The US Food a

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