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911 articles found
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FDA Approves First COVID-19 VaccineToday, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na... -
Coronavirus (COVID-19) Update: August 20, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:As part of the FDA’s effort to protect consumers, on August 19...
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Joint Statement from HHS Public Health and Medical Experts on COVID-19 Booster ShotsEspañolToday, public health and medical experts from the U.S. Department of Health and Human Services (HHS) released the following statement on the Administration’s plan for COVID-19 booster shots for...
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FDA In Brief: FDA Issues a Corporate-Wide Warning Letter to Company Associated with Contaminated Pet Food, Hundreds of Adverse EventsThe following quote is attributed to Steven M. Solomon, M.P.H., D.V.M., director of the FDA’s Center for Veterinary Medicine “The FDA is dedicated to taking all steps possible to help pet o...
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Coronavirus (COVID-19) Update: August 13, 2021The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic:As part of the FDA’s effort to protect consumers, on August 10, the agency issued...
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Coronavirus (COVID-19) Update: FDA Authorizes Additional Vaccine Dose for Certain Immunocompromised IndividualsOn Fri., Aug. 13, 2021, the Centers of Disease Control and Prevention’s Advisory Committee on Immunization Practices outlined clinical recommendations regarding an additional dose of COVID-19 vacci...
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FDA Grants First of its Kind Indication for Chronic Sleep Disorder TreatmentThe U.S. Food and Drug Administration today approved a new indication for Xywav for idiopathic hypersomnia (IH) in adults. IH is an uncommon chronic sleep disorder that causes people to be excessively...
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Coronavirus (COVID-19) Update: August 6, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:Today, FDA announced that it has found certain lots of Astra Z...
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FDA Approves New Treatment for Pompe DiseaseToday, the U.S. Food and Drug Administration approved Nexviazyme (avalglucosidase alfa-ngpt) for intravenous infusion to treat patients 1 year of age and older with late-onset Pompe disease.Patients w...
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FDA In Brief: FDA Reminds Industry of Specific Regulations for the Use of Fluorinated Polyethylene in Food Contact ContainersThe following quote is attributed to Susan Mayne, Ph.D., director of the Center for Food Safety and Applied Nutrition “The FDA is committed to ensuring that food containers are safe for con...