Hana says FDA to review cancer nausea drug
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Cancer-focused biotechnology firm Hana  Biosciences said on Wednesday the U.S. Food and Drug  Administration had accepted Zensana Oral Spray for review.
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U.S. health officials said on Friday they would review whether to take regulatory action over Merck & Co Inc and Schering-Plough's cholesterol medicine Vytorin following the drug's failure to work better than a generic drug in a study of plaque build-up in neck arteries.
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A panel of experts advising the Food and Drug Administration gave strong signals yesterday that it thinks the blockbuster anemia drug called erythropoietin is overused in cancer treatment and may, in fact, be shortening the lives of some patients who take it.
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Description: An advisory committee recommends the FDA issue stronger warnings about the use of antidepressants called SSRIs in children and teenagers.
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Cancer drug shows exceptional promise as it moves toward FDA review.
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The Food and Drug Administration agreed Friday to allow a drug currently used against advanced breast cancer to be prescribed to prevent the disease from recurring in women who have been treated for early forms of the disease.
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Data on approximately 40,000 depressed adults in 234 clinical trials of antidepressants will be examined to see if the drugs increased suicidal thoughts or behaviors, said the US Food and Drug Administration.
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Wyeth said on Tuesday that US regulators will review on an accelerated basis its experimental drug temsirolimus as a first line treatment for advanced renal cell carcinoma.
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The Food and Drug Administration (FDA) learned yesterday from AstraZeneca that a large clinical trial comparing Iressa (gefitinib) with placebo in patients with non-small cell lung cancer who had failed other courses of cancer therapy showed no survival
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U.S. regulators said on Friday they would review a study showing a Merck and Schering-Plough cholesterol drug worked no better than a generic in preventing the build-up of arterial plaque.
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German biotech firm Jerini AG said on Friday that U.S. regulators at the Food and Drug Administration have granted priority review of its Icatibant drug for the treatment of skin-swelling disease hereditary angioedema.
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A Food and Drug Administration reviewer who has criticized the agency for being lax in monitoring drug safety said on Thursday five medicines on the market need close scrutiny for possible side effects.
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An FDA review of AstraZeneca Plc&#39;s (AZN.L: Quote, Profile, Research) (AZN.N: Quote, Profile, Research) Exanta questioned the experimental drug&#39;s
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U.S. regulators said on Friday they would review whether to take action over Merck & Co Inc's  and Schering-Plough Corp's  popular cholesterol medicine Vytorin after a study showed it was no better than a generic drug in preventing the build-up of fatty plaque.
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US Food and Drug Administration staff reviewers on Tuesday questioned clinical data for non-Hodgkin&#39;s lymphoma drug Marqibo, made by Inex Pharmaceuticals Corp.
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Nov. 5, 2004 -- FDA officials announced Friday that they will launch a review of the agency&#39;s drug monitoring policies in the wake of recent high-profile safety concerns about widely used drugs, including antidepressants and Vioxx.
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Pfizer Inc's experimental drug for a deadly form of stomach cancer has been recommended for so-called orphan drug status in the European Union, the European Medicines Agency said.