FDA Seeks to Improve Postapproval Safety Studies for Drugs Used During Pregnancy
The FDA has announced plans to improve postmarketing studies on the effects of medication on pregnant women, in order to improve drug safety and warning labels.
Tag Archives: Clinical Trials
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Injectafer Fails to Prevent Heart Failure in Patients with Iron Deficiency, Study Finds
A new study found that Injectafer failed to help patients with heart failure live longer or avoid hospitalization for heart problems.
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Tecentriq and Avastin Liver Cancer Combo Linked to Patient Deaths in Early Trials
Some patient deaths have been linked to a clinical trial using a combination of Tecentriq and Avastin to prevent the return of liver cancer.
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New Clinical Data Shows Abiomed Impella RP Heart Pump is Safe, Despite Concerns Over Patient Deaths: FDA
The FDA has released clinical trial data on Abiomed Impella RP Heart Pump Systems, declaring the device safe, but updated its warning label to recommend it only be used on…
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GSK Removes Blenrep From U.S. Market, Due Poor Clinical Trial Performance for Multiple Myeloma Drug
The multiple myeloma drug Blenrep is being removed from the U.S. market after the fast-tracked cancer drug failed to perform in a recent clinical trial.
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FDA Calls for Restrictions on Ovarian Cancer Drug Rubraca Due to High Mortality Rates
The FDA is seeking restrictions on the ovarian cancer drug Rubraca, following data indicating it may increase the risk of death in some patients.
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FDA Issues New Draft Guidance on Children’s Use in Clinical Trials
The FDA has proposed new guidelines for safely including children in clinical trials.
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Pediatric Heart Devices Often Approved By FDA Without Clinical Trials Involving Children: Study
A new study finds that many children's heart implants are approved without researchers actually knowing the effect of those devices on children's bodies.
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Ukoniq Side Effects Linked to Increased Risk of Death, FDA Warns, Withdraws Drug Approval
The FDA has withdrawn approval for the lymphoma drug Ukoniq after determining the risk of death outweighs any potential benefits.
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Ukoniq FDA Warning Issued Over Increased Risk of Death with Cancer Drug
The FDA warns that the relatively new cancer drug, Ukoniq, may increase the risk of death in the lymphoma patients it was designed to treat.
