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911 articles found
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FDA Issues Safety Alert for Squamous Cell Carcinoma and Various Lymphomas in Scar Tissue around Breast ImplantsToday, the U.S. Food and Drug Administration issued a safety communication informing patients and providers about reports of squamous cell carcinoma (SCC) and various lymphomas located in the capsule... -
Monkeypox Update: FDA Takes Significant Action to Help Expand Access to TestingToday, the U.S. Food and Drug Administration is announcing steps to further increase monkeypox testing capacity and accessibility nationwide as part of its continued commitment to addressing the ongoi...
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FDA Roundup: September 6, 2022Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA published the 2022: Advancing Regulatory Science at FDA: Focus Areas...
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FDA Roundup: September 2, 2022Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Thursday, the FDA published the FDA Voices: “Using A Whole-Of-Governments Approac...
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FDA Approves First Treatment for Acid Sphingomyelinase Deficiency, a Rare Genetic DiseaseToday, the U.S. Food and Drug Administration approved Xenpozyme (Olipudase alfa) for intravenous infusion in pediatric and adult patients with Acid Sphingomyelinase Deficiency (ASMD), a rare genetic d...
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Coronavirus (COVID-19) Update: FDA Authorizes Moderna, Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster DoseToday, the U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine to authorize bivalent formulations...
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FDA Roundup: August 30, 2022Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA published the FDA Voices: “FDA’s Overdose Prevention Framework Aims t...
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FDA Roundup: August 26, 2022Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, FDA provided additional guidance to help prescribers evaluate potential drug...
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FDA Removes N95 Respirators from Medical Device Shortage List, Signaling Sufficient SupplyToday, the U.S. Food and Drug Administration announced the removal of N95 respirators from the agency’s medical device shortage list, signaling that demand or projected demand for this type of face pr...
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FDA and Mexican Counterparts Report Progress in Food Safety at Second Annual Partnership MeetingToday, the U.S. Food and Drug Administration and its regulatory counterparts in Mexico – the Federal Commission for the Protection from Sanitary Risks (COFEPRIS) and the National Service of Agro-Alime...