April 16, 2024

FDA Roundup: April 16, 2024

For Immediate Release: April 16, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  Today, the […]
April 16, 2024

Drugs@FDA Data Files

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

Drug Trials Snapshots

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

Novel Drug Approvals for 2023

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

Drug Trials Snapshots: VANFLYTA

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

Completed BsUFA III Deliverables

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 […]
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