Press Announcements | FDA - U.S. Food and Drug Administration
2024年1月31日 · Some links in press announcements may no longer be active. For more information, contact FDA’s Office of Media Affairs at 301-796-4540. Get regular FDA email updates delivered on this topic...
News & Events | FDA - U.S. Food and Drug Administration
Press releases and announcements, media contacts and transcripts. Approval information by product type. Upcoming events, past meetings, presentations, transcripts of meetings. …
News Release
2024年12月20日 · News Release ... This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Zepbound (tirzepatide) as a potential treatment for adults with moderate-to-severe obstructive sleep apnea (OSA) and obesity and other milestones relating to Zepbound and its clinical ...
FDA Approves First Generic of Once-Daily GLP-1 Injection to …
2024年12月23日 · The FDA approved the first generic in this class of medications last month with the approval of a generic referencing Byetta (exenatide). Liraglutide injection and certain other GLP-1 medications ...
FDA Approves and Authorizes Updated mRNA COVID-19 Vaccines …
2024年8月22日 · Today's actions relate to updated mRNA COVID-19 vaccines manufactured by ModernaTX Inc. and Pfizer Inc. In early June, the FDA advised manufacturers of licensed and authorized COVID-19 vaccines...
FDA Newsroom | FDA - U.S. Food and Drug Administration
2024年10月2日 · The latest news and events at the U.S. Food and Drug Administration (FDA) and resources for journalists.
U.S. FDA Approves Pfizer’s RSV Vaccine ABRYSVO® for Adults …
2024年10月22日 · In August 2023, the FDA approved ABRYSVO for the prevention of LRTD and severe LRTD caused by RSV in infants from birth up to 6 months of age by active immunization of pregnant individuals at 32 through 36 weeks gestational age.
FDA Approves First Generic of Once-Daily GLP-1 Injection to …
2024年12月23日 · FDA approved the first generic referencing Victoza (liraglutide injection) 18 mg/3 mL, a glucagon-like peptide-1 (GLP-1) receptor agonist indicated to improve glycemic control in adults...
Astellas' VYLOY™ (zolbetuximab-clzb) Approved by U.S. FDA for …
2024年10月18日 · Following today's FDA decision, VYLOY is now approved in five markets worldwide — Japan, the United Kingdom, the European Union, South Korea and the U.S. Japan's Ministry of Health, Labour and...
NIH and FDA leaders call for innovation in development of …
2024年10月15日 · NIH and FDA leaders call for innovation in development of smoking cessation treatments. Commentary emphasizes that engagement across stakeholders is critical to accelerate smoking cessation and reduce smoking-related disease and death.