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911 articles found
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FDA Approves First in the World, First-of-Its-Kind Implant for the Treatment of Rare Bone Disease as a Humanitarian Use DeviceToday, the U.S. Food and Drug Administration approved the Patient Specific Talus Spacer 3D-printed talus implant for humanitarian use. The Patient Specific Talus Spacer is the first in the world and f... -
Coronavirus (COVID-19) Update: February 16, 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, the agency i...
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Coronavirus (COVID-19) Update: February 12, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:This week, the FDA posted the webpage, COVID-19 Vaccine Safety...
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FDA Approves Drug to Reduce Bone Marrow Suppression Caused by ChemotherapyToday, the U.S. Food and Drug Administration approved Cosela (trilaciclib) as the first therapy in its class to reduce the frequency of chemotherapy-induced bone marrow suppression in adults receiving...
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Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for bamlanivimab and etesevimab administered together for the treatment of mild to moderate COVID-19 in adults...
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Coronavirus (COVID-19) Update: February 9, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:Today, the FDA issued a Letter to Health Care Providers on Usi...
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FDA Announces New Resource for Veterinarians and Pet Owners Interested in Clinical Field Studies of Animal Cells, Tissues, and Cell- and Tissue-Based ProductsVeterinary regenerative medicine is a rapidly growing area of product development that offers great promise in the development of novel therapies for animals. These products, which include animal cell...
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Coronavirus (COVID-19) Update: February 5, 2021The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:The FDA has scheduled a meeting of its Vaccines and Related Bi...
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FDA Approves New Treatment For Adults With Relapsed Or Refractory Large-B-Cell LymphomaToday, the U.S. Food and Drug Administration approved Breyanzi (lisocabtagene maraleucel), a cell-based gene therapy to treat adult patients with certain types of large B-cell lymphoma who have not re...
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FDA Authorizes Marketing of Novel Device to Reduce Snoring and Mild Obstructive Sleep Apnea in Patients 18 Years and OlderToday, the U.S. Food and Drug Administration authorized marketing of a new prescription only device intended to reduce snoring and mild obstructive sleep apnea. Unlike devices used while patients slee...