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105 articles found
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FDA Takes Additional Steps to Advance Decentralized Clinical TrialsToday, the U.S. Food and Drug Administration is taking additional steps to support the use of decentralized clinical trials (DCTs) for drugs, biologics and devices, where some or all the trial-related... -
Coronavirus (COVID-19) Update: FDA Authorizes Changes to Simplify Use of Bivalent mRNA COVID-19 VaccinesToday, the U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) of the Moderna and Pfizer-BioNTech COVID-19 bivalent mRNA vaccines to simplify the vaccination schedule for...
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Coronavirus (COVID-19) Update: FDA Authorizes Bivalent Pfizer-BioNTech COVID-19 Vaccine as Booster Dose for Certain Children 6 Months through 4 Years of AgeToday, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent to provide for a single booster dose of the vaccine in chil...
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FDA Approves First Gene Therapy for the Treatment of High-Risk, Non-Muscle-Invasive Bladder CancerToday, the U.S. Food and Drug Administration approved Adstiladrin (nadofaragene firadenovec-vncg), a non-replicating (cannot multiply in human cells) adenoviral vector based gene therapy indicated for...
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Coronavirus (COVID-19) Update: FDA to Hold Advisory Committee Meeting to Discuss Future Vaccination Regimens Addressing COVID-19On Jan. 26, 2023, the U.S. Food and Drug Administration will hold a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) to consider whether and how the composition for...
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Coronavirus (COVID-19) Update: FDA Authorizes Updated (Bivalent) COVID-19 Vaccines for Children Down to 6 Months of AgeToday, the U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) of the updated (bivalent) Moderna and Pfizer-BioNTech COVID-19 vaccines to include use in children down to...
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FDA Approves First Gene Therapy to Treat Adults with Hemophilia BToday, the U.S. Food and Drug Administration approved Hemgenix (etranacogene dezaparvovec), an adeno-associated virus vector-based gene therapy for the treatment of adults with Hemophilia B (congenita...
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Coronavirus (COVID-19) Update: FDA Authorizes Moderna and Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose in Younger Age GroupsToday, the U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) of the Moderna COVID-19 Vaccine, Bivalent and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent to authorize t...
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FDA Approves Vaccine for Use During Third Trimester of Pregnancy to Prevent Whooping Cough in Infants Younger Than Two Months of AgeToday, the U.S. Food and Drug Administration approved Boostrix (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed [Tdap]) for immunization during the third trimester...
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FDA and NIH Launch Public-Private Partnership for Rare Neurodegenerative DiseasesToday, the U.S. Food and Drug Administration and the National Institutes of Health (NIH) announced the launch of the Critical Path for Rare Neurodegenerative Diseases (CP-RND) – a public-private partn...