FDA Reviewers Mixed Over Two New Cancer Drugs
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U.S. FDA staff reviewers on Tuesday  said data on a new non-Hodgkin's lymphoma drug made by Inex  Pharmaceuticals Corp. and Enzon Pharmaceuticals Inc. may be  unreliable due to the trial's structure and size.
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Almost one-fifth of the Food and Drug Administration scientists surveyed two years ago as part of an official review said they had been pressured to recommend approval of a new drug despite
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Misaligned incentives are leading two potentially life-saving drugs for treating lymphoma to go underused.
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U.S. regulators said on Thursday they were reviewing two recent studies that provided more evidence of serious risks for some cancer patients treated with anemia drugs sold by Amgen Inc  and Johnson & Johnson .
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The US Food and Drug Administration approved a new drug to treat patients with advanced lung cancer. It&#39;s called Alimta. Patients receive ten minute infusions of the drug every three weeks on an outpatient basis.
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The move follows recent studies suggesting that the medications might cause heart attacks or make cancer worse in some patients.
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As the Food and Drug Administration prepares to make recommendations about Pfizer&#39;s (PFE:NYSE - news - research) Celebrex, the companies that ultimately pay for the drug aren&#39;t leaping to conclusions merely because one recent study showed patients taking
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WASHINGTON -- Women with an aggressive form of advanced breast cancer that other treatments have failed to stop gained a new option yesterday with the approval of a novel drug -- but how much benefit it offers is unclear.
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New reports accuse another drug company of being too slow to pull a dangerous medication from the market and question the ability of the federal Food and Drug Administration to protect the public from such risks.
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Federal advisers heard conflicting data today about the safety of new drug-oozing stents used to keep clogged arteries open as the experts struggled to advise government regulators about whether the risks of the devices outweigh their benefits for millions of patients.
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A new type of breast cancer drug is superior to the old standard, tamoxifen, in older women and should now be the first drug used to treat the cancer, U.S. and British researchers said on Wednesday.
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Here's what a newly approved drug looks like.
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Almost one-fifth of agency scientists surveyed two years ago as part of an official review said they had been pressured to recommend approval of a new drug despite reservations.
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U.S. Food and Drug Administration staff reviewers on Tuesday questioned clinical data for non-Hodgkin's lymphoma drug Marqibo, made by Inex Pharmaceuticals Corp. and Enzon Pharmaceuticals Inc..
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A report last week tying the Type 2 diabetes pill Avandia to increased risk for heart attack and heart-related deaths prompted a flood of calls to local doctors and Internet postings from patients seeking advice about whether to continue taking the commonly prescribed medication.
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The FDA asks for more data about Avastin, which could be used to treat various cancers.
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WASHINGTON The first new cancer drug in ten years that is specifically designed to help children is a step closer to approval. An advisory panel at the Food and Drug Administration is recommending the use