http://www.fda.gov/ en http://www.fda.gov/news-events/press-announcements/fda-conditionally-approves-first-drug-anemia-cats-chronic-kidney-disease FDA conditionally approved Varenzin-CA1 (molidustat oral suspension) the first drug for the control of nonregenerative anemia associated with chronic kidney disease (CKD) in cats. Mon, 01 May 2023 13:55:17 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-conditionally-approves-first-drug-anemia-cats-chronic-kidney-disease http://www.fda.gov/news-events/press-announcements/fda-roundup-april-28-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Fri, 28 Apr 2023 15:47:52 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-april-28-2023 http://www.fda.gov/news-events/press-announcements/fda-approves-first-orally-administered-fecal-microbiota-product-prevention-recurrence-clostridioides FDA approves Vowst, the first orally administered fecal microbiota product. Vowst is approved for the prevention of recurrence of Clostridioides difficile infection in individuals 18 years of age and older, following completion of antibacterial treatment for recurrent CDI. Wed, 26 Apr 2023 18:03:02 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-approves-first-orally-administered-fecal-microbiota-product-prevention-recurrence-clostridioides http://www.fda.gov/news-events/press-announcements/fda-roundup-april-21-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Fri, 21 Apr 2023 15:15:16 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-april-21-2023 http://www.fda.gov/news-events/press-announcements/fda-roundup-april-18-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Tue, 18 Apr 2023 15:33:38 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-april-18-2023 http://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-changes-simplify-use-bivalent-mrna-covid-19-vaccines The FDA amended the emergency use authorizations (EUAs) of the Moderna and Pfizer-BioNTech COVID-19 bivalent mRNA vaccines to simplify the vaccination schedule for most individuals. Tue, 18 Apr 2023 09:09:43 EDT FDA http://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-changes-simplify-use-bivalent-mrna-covid-19-vaccines http://www.fda.gov/news-events/press-announcements/fda-approves-cell-therapy-patients-blood-cancers-reduce-risk-infection-following-stem-cell FDA approves Omisirge (omidubicel-onlv), a nicotinamide modified allogeneic (donor) cord blood-based cell therapy to quicken the recovery time of neutrophils (a subset of white blood cells) in the body and reduce the risk of infection following stem cell transplantation. Mon, 17 Apr 2023 13:01:06 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-approves-cell-therapy-patients-blood-cancers-reduce-risk-infection-following-stem-cell http://www.fda.gov/news-events/press-announcements/fda-roundup-april-14-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Fri, 14 Apr 2023 16:43:10 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-april-14-2023 http://www.fda.gov/news-events/press-announcements/fda-roundup-april-11-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Tue, 11 Apr 2023 14:21:35 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-april-11-2023 http://www.fda.gov/news-events/press-announcements/fda-roundup-april-7-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Fri, 07 Apr 2023 16:04:15 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-april-7-2023 http://www.fda.gov/news-events/press-announcements/fda-commissioner-and-chief-scientist-announce-decision-withdraw-approval-makena Today, the FDA announced the final decision to withdraw approval of Makena—a drug that had been approved under the accelerated approval pathway. This drug was approved to reduce the risk of preterm birth in women pregnant with one baby who have a history of spontaneous preterm birth. Thu, 06 Apr 2023 09:58:19 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-commissioner-and-chief-scientist-announce-decision-withdraw-approval-makena http://www.fda.gov/news-events/press-announcements/fda-roundup-april-4-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Tue, 04 Apr 2023 14:53:23 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-april-4-2023 http://www.fda.gov/news-events/press-announcements/fda-moves-forward-mail-back-envelopes-opioid-analgesics-dispensed-outpatient-settings The FDA announced it is requiring manufacturers of opioid analgesics dispensed in outpatient settings to make prepaid mail-back envelopes available to outpatient pharmacies and other dispensers as an additional opioid analgesic disposal option for patients. Mon, 03 Apr 2023 14:37:31 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-moves-forward-mail-back-envelopes-opioid-analgesics-dispensed-outpatient-settings http://www.fda.gov/news-events/press-announcements/fda-roundup-march-31-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Fri, 31 Mar 2023 16:45:20 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-march-31-2023 http://www.fda.gov/news-events/press-announcements/fda-approves-first-over-counter-naloxone-nasal-spray The U.S. Food and Drug Administration approved the first naloxone nasal spray product available without a prescription. Wed, 29 Mar 2023 08:28:42 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-approves-first-over-counter-naloxone-nasal-spray http://www.fda.gov/news-events/press-announcements/fda-roundup-march-28-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Tue, 28 Mar 2023 15:25:04 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-march-28-2023 http://www.fda.gov/news-events/press-announcements/fda-outlines-immediate-national-strategy-further-increase-resiliency-us-infant-formula-market The FDA is releasing an immediate national strategy outlining actions the agency will take immediately to help ensure one of the nation’s most vulnerable populations continues to have access to safe, nutritious infant formula and to increase the resiliency of the U.S. infant formula market and suppl Tue, 28 Mar 2023 08:55:57 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-outlines-immediate-national-strategy-further-increase-resiliency-us-infant-formula-market http://www.fda.gov/news-events/press-announcements/fda-roundup-march-24-2023 The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Fri, 24 Mar 2023 15:27:52 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-roundup-march-24-2023 http://www.fda.gov/news-events/press-announcements/fda-works-further-improve-nutrition-reduce-diet-related-chronic-disease-dietary-guidance-statements FDA Works to Further Improve Nutrition, Reduce Diet-Related Chronic Disease with Dietary Guidance Statements on Food Labels Fri, 24 Mar 2023 10:26:45 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-works-further-improve-nutrition-reduce-diet-related-chronic-disease-dietary-guidance-statements http://www.fda.gov/news-events/press-announcements/fda-issues-draft-guidance-aimed-improving-oncology-clinical-trials-accelerated-approval The FDA issued draft guidance to industry regarding clinical trial design and confirmatory studies to support accelerated approval applications in oncology. Fri, 24 Mar 2023 09:32:00 EDT FDA http://www.fda.gov/news-events/press-announcements/fda-issues-draft-guidance-aimed-improving-oncology-clinical-trials-accelerated-approval