FDA gives Jerini angioedema drug priority review
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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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Washington, Dec 16 : One-fifth of the US Food and Drug Administration (FDA) scientists surveyed as part of an official review have said they had been pressured to recommend approval of a new drug despite their reservations about its safety, effectiveness
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A World Health Organization (WHO) report released Thursday highlights world medicine priorities. The report, named &quot;Priority Medicines for Europe and the World&quot;,recommends ways
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The Food and Drug Administration will establish a new independent Drug Safety Oversight Board to monitor FDA-approved medicines once they're on the market and update physicians and patients with emerging information on risks and benefits.
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U.S. lawmakers and health officials  are moving to give more independence to an office that reviews  drug safety, but some experts say ensuring medicines are  studied after they hit the market is more important than the  bureaucratic pecking order.
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U.S. regulators said on Friday they were reviewing the safety of Allergan Inc's  Botox and a competing product, after reports of deaths and serious reactions in some patients.
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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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Pharmaceutical firm Wyeth said Tuesday that the Food and Drug Administration granted fast-track status to its experimental cancer drug temsirolimus as an initial treatment for patients with advanced kidney ...
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Regulators said on Friday they were reviewing the safety of Allergan Inc's  Botox and a competing product after reports of deaths and serious reactions in some patients.
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German drug maker Schering AG (SCHG.DE: Quote , Profile , Research ) was boosted on Thursday as the U.S. Food and Drug Administration granted its Bonefos treatment "priority review" for preventing bone tumours ...
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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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The Food and Drug Administration yesterday called for an evaluation of all prevention studies involving two controversial painkillers - Celebrex and Bextra - to ensure adequate protection for participants who use the pills.
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Wyeth said on Tuesday that U.S.  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 European Medicines Agency is to review all drugs in the same class as Vioxx after US pharmaceutical giant Merck withdrew the arthritis drug.
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An internal survey of Food and Drug Administration scientists conducted by the Health and Human Services Office of the Inspector General revealed safety concerns about the FDAâs approval process and monitoring of marketed drugs, according to a press
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GAITHERSBURG, Maryland  - The Food and Drug Administration should consider telling patients and doctors that the use of drug-coated heart stents in unapproved, high-risk cases can lead to greater complications, a panel of medical experts said on Friday.
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The US Food and Drug Administration has granted fast-trackapproval to Tarceva (erlotinib) to treat advanced non-small cell lungcancer that has failed to respond to other therapy.