April 16, 2024
Below you will find a compressed data file of the Drugs@FDA database. It does not include the scripts (programming) we use to produce the online version […]
April 16, 2024
ACCRUFER ferric maltol July 25, 2019 Treatment of low iron stores Accrufer ADAKVEO crizanlizumab-tmca November 15, 2019 Treatment of vasooclusive crises in patients with sickle cell […]
April 16, 2024
1. Leqembi lecanemab-irmb 1/6/2023 To treat Alzheimer’s diseasePress Release 2. Brenzavvy bexagliflozin 1/20/2023 To improve glycemic control in adults with type 2 diabetes mellitus as an […]
April 16, 2024
At least 19 people from nine states have reported serious reactions after receiving botulinum toxin injections from unlicensed or untrained individuals or in non-healthcare settings, such […]
April 16, 2024
What are the possible side effects (results of trials used to assess safety)? Table 4 and Table 5 summarize adverse reactions and laboratory abnormalities in the […]
April 16, 2024
Since the passage of the Biosimilar User Fee Act (BsUFA) in 2012, user fees have played an important role in expediting the process for the review […]
April 16, 2024
The Food and Drug Administration Amendments Act (FDAAA) requires that the FDA track and make publicly available certain pediatric information resulting from pediatric clinical trials pursuant […]
April 16, 2024
An interim analysis of an ongoing extension study supports the long-term safety and efficacy of the oral calcitonin gene-related peptide (CGRP) receptor antagonist atogepant (Qulipta) to […]
April 16, 2024
Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Devices and Radiological Health Center for Drug Evaluation and Research Center for Food […]