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Today, the U.S. Food and Drug Administration approved Pradaxa (dabigatran etexilate) oral pellets to treat children 3 months to less than 12 years old with…
The U.S. Food and Drug Administration today approved a nasal antihistamine for nonprescription use through a process called a partial prescription to nonprescription switch. The…
The following quote is attributed to William Maisel, M.D., M.P.H., director of the Office of Product Evaluation and Quality, in the FDA’s Center for Devices…
The following quote is attributed to William Maisel, M.D., director of the Office of Product Evaluation and Quality in FDA’s Center for Devices and Radiological…
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: Following our update on…
Today, the U.S. Food and Drug Administration approved StrataGraft for the treatment of adult patients with thermal burns containing intact dermal elements (remaining deep skin…
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: On June 10, the…
Following careful review and deliberation, the U.S. Food and Drug Administration is taking important steps that will allow a critically needed supply of the Janssen…
The following quote is attributed to Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic…
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: The White House, the…
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