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911 articles found
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Coronavirus (COVID-19) Update: June 11, 2021The 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 FDA issued a safety communication warning the... -
FDA Takes Steps to Increase Availability of COVID-19 VaccineFollowing 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 (Johnson & Johnson) COVID-19 Vaccin...
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FDA In Brief: FDA Provides Guidance on Measuring Patient-Reported Outcomes in Cancer Clinical TrialsThe 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 Diseases in the FDA’s Center for Dr...
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Coronavirus (COVID-19) Update: June 8, 2021The 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 U.S. Department of Health and Human Servi...
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FDA Grants Accelerated Approval for Alzheimer’s DrugToday, the U.S. Food and Drug Administration approved Aduhelm (aducanumab) for the treatment of Alzheimer’s, a debilitating disease affecting 6.2 million Americans. Aduhelm was approved using the acce...
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FDA Approves First Treatment for Patients with Plasminogen Deficiency, a Rare Genetic DisorderToday, the U.S. Food and Drug Administration approved Ryplazim (plasminogen, human-tvmh) for the treatment of patients with plasminogen deficiency type 1, also referred to as hypoplasminogenemia, a di...
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Coronavirus (COVID-19) Update: June 4, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:On June 1, the FDA approved an abbreviated new drug applicatio...
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FDA Approves New Drug Treatment for Chronic Weight Management, First Since 2014Today, the U.S. Food and Drug Administration approved Wegovy (semaglutide) injection (2.4 mg once weekly) for chronic weight management in adults with obesity or overweight with at least one weight-re...
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FDA In Brief: FDA provides new guidance to further enhance the security of prescription drugs in the U.S. supply chainThe following quote is attributed to Donald D. Ashley, J.D., Director of the Office of Compliance for FDA's Center for Drug Evaluation and Research “Ensuring the quality of prescription dru...
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FDA Alerts Health Care Providers to Stop New Implants of Certain Ventricular Assist Device SystemThe U.S. Food and Drug Administration is alerting health care providers to no longer implant end-stage heart failure patients with Medtronic’s Heartware Ventricular Assist Device (HVAD) System due to...