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Praxbind (idarucizumab) has been approved for use in patients who are taking the anticoagulant Pradaxa (dabigatran) when there is an urgent need to reverse Pradaxa's anticoagulant effects

FDA Approves Praxbind to Reverse Pradaxa’s Effect

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Praxbind cleared for emergency use with Pradaxa when bleeding can't be controlled
The U.S. Food and Drug Administration on Monday expanded its approval for the Optune device to include newly diagnosed glioblastoma multiforme.

FDA Approves Optune Device for Newly Diagnosed Glioblastoma

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Newly sanctioned to treat just-diagnosed patients, in combination with temozolomide
Aristada (aripiprazole lauroxil) extended-release injection has been approved by the U.S. Food and Drug Administration to treat schizophrenia

FDA OKs Long-Acting Atypical Antipsychotic for Schizophrenia

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Aristada (aripiprazole lauroxil) is injected every four-to-six weeks
Keytruda (pembrolizumab) has been approved by the U.S. Food and Drug Administration to treat advanced cases of non-small-cell lung cancer with tumors that express the PD-L1 protein. Keytruda is approved for use with the PD-L1 IHC 22C3 pharmDx test

FDA Approves Keytruda for Advanced NSCLC

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Approved for use with PD-L1 IHC 22C3 pharmDx test
Two new diabetes treatments

FDA Approves Two New Medications for Diabetes

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Tresiba and Ryzodeg approved for use in adults with type 1 and 2 diabetes mellitus
The combination pill Lonsurf (trifluridine and tipiracil) has been approved by the U.S. Food and Drug Administration to treat metastatic colorectal cancer in patients who aren't responding to other treatments

FDA Approves Lonsurf for Metastatic Colorectal Cancer

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For patients with metastatic CRC previously treated with chemotherapy, biological therapy
A new antipsychotic drug to treat schizophrenia and bipolar disorder in adults has been approved by the U.S. Food and Drug Administration. The drug

FDA Approves New Drug for Schizophrenia, Bipolar Disorder

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Vraylar is an atypical antipsychotic taken once a day
The U.S. Food and Drug Administration has ordered the R.J. Reynolds Tobacco Co. to stop selling four new cigarette brands because submissions for these products did not meet requirements set forth in the Federal Food

FDA Orders Tobacco Company to Stop Sales of New Cigarettes

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Says products didn't meet requirement that they be substantially the same as existing cigarettes
The U.S. Food and Drug Administration announced new steps Thursday to improve the cleanliness of food manufacturing plants in the wake of a string of foodborne illness outbreaks.

FDA Announces New Steps to Improve Food Safety in U.S.

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New rules focus on cleanliness of manufacturing facilities
The U.S. Food and Drug Administration has issued a warning that injectable skin-lightening products are potentially unsafe and ineffective.

FDA Issues Warning Regarding Injectable Skin Lighteners

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Injectable products may contain unknown substances or contaminants