Drug Approvals and Databases | FDA - U.S. Food and Drug …
Additional topics include: approved REMS, drug shortages, and the Orange book. CDER highlights key Web sites. Web page provides quick links to everything from acronyms to …
Is It Really 'FDA Approved'? - U.S. Food and Drug Administration
2022年5月10日 · The FDA is responsible for protecting public health by regulating human drugs and biological products, animal drugs, medical devices, tobacco products, food (including …
Approvals of FDA-Regulated Products
On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.
FDA Approves and Authorizes Updated mRNA COVID-19 Vaccines …
FDA approved and authorized for emergency use updated mRNA COVID-19 vaccines (2024-2025 formula) to more closely target currently circulating variants to prevent COVID-19 and to …
FDA Approves First Medication for Obstructive Sleep Apnea
Today, the FDA approved the first medication for the treatment of moderate to severe obstructive sleep apnea in adults with obesity, to be used in combination with a reduced-calorie diet and ...
FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss
2024年10月2日 · Many of the adverse events reported for compounded products appear to be consistent with adverse events related to the FDA-approved versions of these products. As of …
FDA Approves First Generic of Once-Daily GLP-1 Injection to …
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 and ...
Development & Approval Process | Drugs | FDA
Get to know FDA’s drug development and approval process -- ensuring that drugs work and that the benefits outweigh their known risks.
FDA approves durvalumab for limited-stage small cell lung cancer
On December 4, 2024, the Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca) for limited-stage small cell lung cancer (LS-SCLC).
FDA approves neoadjuvant/adjuvant durvalumab
On August 15, 2024, the FDA approved durvalumab (Imfinzi, AstraZeneca) with platinum-containing chemotherapy as neoadjuvant treatment, followed by single-agent durvalumab as …