Αποτελέσματα Αναζήτησης
2 Ιαν 2024 · The FDA’s Center for Drug Evaluation and Research (CDER) approved 55 new drugs in 2023, as the small molecule and biologic pharmacopoeia continues to grow. This cohort is nearly 50% bigger...
26 Φεβ 2024 · The US Food and Drug Administration (FDA) approved a record-breaking 71 new medicines in 2023. There were one or two controversial decisions and a slight drop in first-in-class approvals.
26 Ιουλ 2024 · Want to know what's new on drugs from FDA? This page provides quick links to the latest on a variety of topics including: drug approvals, safety warnings, drug shortages, etc.
3 Ιαν 2023 · Nature Reviews Drug Discovery - The FDA approved 37 novel drugs in 2022, the fewest to pass regulatory scrutiny since 2016.
25 Οκτ 2023 · Guidance documents represent the FDA's current thinking on a particular subject. New guidance documents are listed here for three months.
26 Ιουν 2023 · Data analysis was performed between October 28 and November 11, 2022. From 2017 to 2019, the FDA approved 107 therapeutics for 146 supplemental new indications, including 99 small molecule drugs (67.8%) and 47 biologics (32.2%) (Table).
8 Αυγ 2023 · The 21st Century Cures Act, enacted in 2017, gave the US Food and Drug Administration (FDA) greater flexibility to apply evidence-based standards for novel drug approvals. 1 To evaluate current practice, we summarize evidence supporting the 37 drugs approved in 2022.
