http://www.fda.gov/ en http://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-acid-sphingomyelinase-deficiency-rare-genetic-disease The FDA approved Xenpozyme (Olipudase alfa) for intravenous infusion in pediatric and adult patients with Acid Sphingomyelinase Deficiency (ASMD), a rare genetic disease that causes premature death. Wed, 31 Aug 2022 13:23:19 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-acid-sphingomyelinase-deficiency-rare-genetic-disease http://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-moderna-pfizer-biontech-bivalent-covid-19-vaccines-use The FDA amended the emergency use authorizations (EUAs) of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine to authorize bivalent formulations of the vaccines for use as a single booster dose at least two months following primary or booster vaccination. Wed, 31 Aug 2022 09:42:22 EDT FDA http://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-moderna-pfizer-biontech-bivalent-covid-19-vaccines-use http://www.fda.gov/news-events/press-announcements/fda-roundup-august-30-2022 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Tue, 30 Aug 2022 15:08:48 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-august-30-2022 http://www.fda.gov/news-events/press-announcements/fda-roundup-august-26-2022 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Fri, 26 Aug 2022 15:37:23 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-august-26-2022 http://www.fda.gov/news-events/press-announcements/fda-removes-n95-respirators-medical-device-shortage-list-signaling-sufficient-supply Today, the FDA announced the removal of N95 respirators from the agency’s medical device shortage list. Fri, 26 Aug 2022 11:28:16 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-removes-n95-respirators-medical-device-shortage-list-signaling-sufficient-supply http://www.fda.gov/news-events/press-announcements/fda-and-mexican-counterparts-report-progress-food-safety-second-annual-partnership-meeting Today, the U.S. Food and Drug Administration and its regulatory counterparts in Mexico COFEPRIS and SENASICA held the second annual Food Safety Partnership Meeting. Thu, 25 Aug 2022 16:42:16 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-and-mexican-counterparts-report-progress-food-safety-second-annual-partnership-meeting http://www.fda.gov/news-events/press-announcements/fda-roundup-august-23-2022 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Tue, 23 Aug 2022 16:22:13 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-august-23-2022 http://www.fda.gov/news-events/press-announcements/fda-roundup-august-19-2022 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Fri, 19 Aug 2022 17:17:03 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-august-19-2022 http://www.fda.gov/news-events/press-announcements/fda-warns-manufacturer-marketing-illegal-flavored-nicotine-gummies Today, the U.S. Food and Drug Administration issued a warning letter for marketing illegal flavored nicotine gummies – the first warning letter for this type of product. Thu, 18 Aug 2022 11:13:22 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-warns-manufacturer-marketing-illegal-flavored-nicotine-gummies http://www.fda.gov/news-events/press-announcements/fda-approves-first-cell-based-gene-therapy-treat-adult-and-pediatric-patients-beta-thalassemia-who FDA approves Zynteglo (betibeglogene autotemcel), the first cell-based gene therapy for the treatment of adult and pediatric patients with Beta-thalassemia who require regular red blood cell (RBC) transfusions. Wed, 17 Aug 2022 13:22:25 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-approves-first-cell-based-gene-therapy-treat-adult-and-pediatric-patients-beta-thalassemia-who http://www.fda.gov/news-events/press-announcements/fda-roundup-august-16-2022 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Tue, 16 Aug 2022 15:39:38 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-august-16-2022 http://www.fda.gov/news-events/press-announcements/fda-finalizes-historic-rule-enabling-access-over-counter-hearing-aids-millions-americans FDA issues historic final rule to improve access to affordable hearing aids for millions of Americans with perceived mild to moderate hearing impairment. Tue, 16 Aug 2022 08:52:23 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-finalizes-historic-rule-enabling-access-over-counter-hearing-aids-millions-americans http://www.fda.gov/news-events/press-announcements/fda-roundup-august-12-2022 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Fri, 12 Aug 2022 15:21:48 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-august-12-2022 http://www.fda.gov/news-events/press-announcements/fda-infant-formula-update-august-10-2022 FDA exercises enforcement discretion to Reckitt Nutrition/Mead Johnson Nutrition to import Base Powder for PurAmino Hypoallergenic Infant Formula (amino acid-based infant formula with iron) infant formula products from Mexico following review of nutritional adequacy and safety information, including Wed, 10 Aug 2022 17:19:30 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-infant-formula-update-august-10-2022 http://www.fda.gov/news-events/press-announcements/monkeypox-update-fda-authorizes-emergency-use-jynneos-vaccine-increase-vaccine-supply The FDA issued an emergency use authorization (EUA) for the JYNNEOS vaccine to increase vaccine supply by up to five-fold and to allow for individuals under 18 years of age determined to be at high risk of monkeypox infection to receive the vaccine. Tue, 09 Aug 2022 15:31:39 EDT FDA http://www.fda.gov/news-events/press-announcements/monkeypox-update-fda-authorizes-emergency-use-jynneos-vaccine-increase-vaccine-supply http://www.fda.gov/news-events/press-announcements/fda-roundup-august-9-2022 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Tue, 09 Aug 2022 12:54:30 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-august-9-2022 http://www.fda.gov/news-events/press-announcements/fda-issues-warning-letters-three-companies-selling-unapproved-new-drugs-mole-and-skin-tag-removal Today, the FDA issued three warning letters to companies for introducing products for mole and skin tag removal into interstate commerce that are unapproved new drugs. Tue, 09 Aug 2022 10:25:40 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-issues-warning-letters-three-companies-selling-unapproved-new-drugs-mole-and-skin-tag-removal http://www.fda.gov/news-events/press-announcements/fda-roundup-august-5-2022 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Fri, 05 Aug 2022 14:04:59 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-august-5-2022 http://www.fda.gov/news-events/press-announcements/fda-infant-formula-update-august-5-2022 FDA Infant Formula Update: August 5 Nestlé (The Netherlands) Fri, 05 Aug 2022 11:39:38 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-infant-formula-update-august-5-2022 http://www.fda.gov/news-events/press-announcements/fda-approves-first-targeted-therapy-her2-low-breast-cancer FDA Approves First Targeted Therapy for HER2-Low Breast Cancer Fri, 05 Aug 2022 11:25:11 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-approves-first-targeted-therapy-her2-low-breast-cancer