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FDA Approves Gleevec for Rare Gastrointestinal Cancer

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The U.S. Food and Drug Administration granted Gleevec (imatinib) regular approval for use in adult patients following surgical removal of CD117-positive gastrointestinal stromal tumors (GIST). Today’s action also highlights an increase in overall patient survival when the drug is taken for 36 months rather than the standard 12 months of treatment.

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FDA Approves Safety Test for MS Drug

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Tysabri, one of the few drugs approved to treat multiple sclerosis, is getting a label makeover courtesy of the FDA. The new look shows off a newly approved safety test for patients.

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Cephalon, Inc. Issues Voluntary Nationwide Recall of Treanda

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Cephalon, Inc. is voluntarily recalling Treanda® (bendamustine HCL) for Injection 25mg/8mL; lot TB30111, expiration date 12/2012. This product lot is being recalled due to the presence of particulate matter found in a single vial, which has been identified as glass fragments.

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FDA Approves Inlyta to Treat Patients With a Type of Advanced Kidney Cancer

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The U.S. Food and Drug Administration today approved Inlyta (axitinib) to treat patients with advanced kidney cancer (renal cell carcinoma) who have not responded to another drug for this type of cancer.

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FDA Versus Ranbaxy

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The Department of Justice, on behalf of the U.S. Food and Drug Administration, has filed a consent decree of permanent injunction against generic drug manufacturer Ranbaxy in the U.S. District Court of Maryland.

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FDA Approves Subcutaneous Administration of Takeda Drug Velcade

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The Takeda Oncology Company with its parent company Takeda Pharmaceutical Company Limited announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for Velcade (bortezomib).

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Acid Reflux Device Close to FDA Approval

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A FDA panel has given unanimous support to LINX, an implantable device to treat chronic and severe acid reflux. That means LINX is one step closer to being available for US patients.

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Birth Control Pill Debate Heats Up

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The support of two advisory committees to the FDA for birth control pills with drospirenone is in question.  A industry watchdog group pointed out various relationships among committee members.

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Gel to Prevent Preemies a No-Go

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A vaginal gel containing progesterone that developers hoped would prevent early birth was rejected by the FDA for lack of adequate evidence that it's effective.

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Voraxaze Approved To Treat Toxic Methotrexate Levels

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The U.S. Food and Drug Administration approved Voraxaze (glucarpidase) to treat patients with toxic levels of methotrexate in their blood due to kidney failure.

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