Tuesday 21 May 2013
 
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FDA

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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US new drug approvals hit 16-year high

US regulators approved 39 new drugs in 2012, the most in 16 years, suggesting that pharmaceutical makers are poised for growth after losing billions of dollars in recent years to generic drug makers because of patent expirations.

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FDA staff question Pfizer arthritis drug benefits

US drug reviewers on Monday questioned whether the benefits of Pfizer's  experimental treatment for rheumatoid arthritis outweighed its risks of cancerous cells and infections. The Food and Drug Administration staff said the drug, cal

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FDA approves ‘osteoporosis’ tablet

EffRx Pharmaceuticals has announced that US Food and Drug Administration (FDA) has approved Binosto (alendronate sodium) Effervescent Tablets, previously known as EX101. The tablets are used for the treatment of osteoporosis in postmenopau

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New diabetes drug wins approval

The US Food and Drug Administration (FDA) has approved Jentadueto (linagliptin/metformin hydrochloride) tablets for adults with Type 2 diabetes. The new tablet combines the dipeptidyl peptidase-4 (DPP-4) inhibitor, linagliptin and metformi

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Diabetes breakthrough stalled in safety debate

It's a dream of medical science that looks tantalizingly within reach: the artificial pancreas, a potential breakthrough treatment for the scourge of type 1 diabetes. Meant to mimic the function of a real pancreas, the artificial versi

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US alerts against repackaged injections

The US Food and Drug Administration (FDA) has alerted health care professionals that repackaged intravitreal injections of Avastin (bevacizumab) have caused a cluster of serious eye infections in the Miami, Florida. The Florida Department

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FDA panel rejects Avastin use for breast cancer

US health advisers unanimously rejected use of the drug Avastin for breast cancer, dealing a blow to its manufacturer and patients who insisted that the medicine saved their lives. Advisers to the US Food and Drug Administration agreed tha

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FDA backs GSK, Valeant epilepsy drug

The US Food and Drug Administration gave its limited approval on Monday for GlaxoSmithKline's and Valeant Pharmaceuticals International's  new epilepsy drug Potiga. The drug, known generically as ezogabine, will not be availab

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