The past year was a return to form for approvals of new drugs by the US Food and Drug Administration. There were 55 new molecular entities that cleared the FDA's hurdles in 2023. That number is up dramatically from the 37 the agency approved in 2022 and similar to the pace the agency...
With 54 new drugs and seven cellular and gene therapy products, the approvals by the US Food and Drug Administration (FDA) recovered 2023 from the 2022 dent back to the levels of 2020–2021. As in previous years of this annual review, we assign these new drugs to one of three levels o...
美国🇺🇸FDA。 50 new drugs received FDA approval in 2024 - down slightly from 55 in 2023 审批这么慢 Trump要动手了
the PROTAC degrades the protein continuously. It is also far more potent and can be used to treat more-severe diseases. Most of the PROTAC drugs currently in clinical trials target some form of cancer, but in the
(seven in 2023, and eleven in 2024, Table1). The drugs encompass small molecules, peptides, macromolecules (immunoglobulins, antibodies), and one conjugate of an antibody plus a small molecule. Before the 18 entities are described in terms of their pharmacological properties and indications (see...
Clinical trials focusing on new drugs for AD were documented in 2020, but subsequent developments have emerged since then. Notably, the US-FDA has approved Aducanumab and Lecanemab, both antibodies targeting amyloid, marking the end of a nearly two-decade period without new AD drugs. In this ...
Consider the headline from STAT, “FDA purges material on clinical trial diversity from its site, showing stakes of Trump DEI ban .” True. Now the subhead, “The scrubbing could affect the ways researchers and companies test drugs and medical devices.” Key word, “could.” The great journ...
Food and Drug Administration (FDA)-related drug information including one on the additional drugs approved by the FDA, one on drugs with pending FDA approval, and one on drug license applications filed by drug manufacturers.doi:10.1310/hpj4504-332Baker, Danial E....
This monthly feature will help readers keep current on new drugs, new indications, dosage forms, and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if there are any questions, please let us know at hos...
Similar to previous years, many of these drugs are likely to undergo accelerated approval processes to address urgent medical needs, particularly for rare diseases. This review provides an overview of the synthesis and clinical applications of NCEs approved by the FDA in 2024. The increasing ...