Gadopiclenol: Reducing Gadolinium Retention Risks Through Coordination Chemistry

You can download our compilation of the 10 first-in-class large molecule drug approvals from 2022 below, which includes structural illustrations, drug targets and mechanisms of action, doses and routes of administration, and indication.

This summary of major clinical updates from November 2024 covers FDA approvals, the initiation of new clinical trials, notable trial outcomes for key drug candidates, and news on paused and discontinued trials and programs.

This summary of September's major clinical updates features FDA approvals, drug withdrawals, anticipated regulatory decisions, notable trial results, new NDA submissions, clinical trial setbacks, and the initiation of new clinical trials.

In April 2024, there were promising examples of drug repurposing, significant clinical and regulatory milestones for therapies aimed at rare and pediatric diseases, the initiation of a rolling NDA submission for suzetrigine, substantial billion-dollar acquisitions, and positive trial results were reported for both a D1/D5 receptor agonist and a PARP1 inhibitor. However, the industry also had setbacks as demonstrated by the failed clinical trials for an MNK inhibitor and an NMDA receptor modulator. In case you missed anything, here’s a recap of the most notable news highlights from April 2024!

Relyvrio, developed by Amylyx Pharmaceuticals, is a combination treatment of sodium phenylbutyrate and taurursodiol, approved by the FDA in 2022 for ALS (“Lou Gehrig’s disease”). The approval was controversial, with an Advisory Committee initially voting against approval based on Ph. II data. Now, Ph. III data have confirmed the drug is no better than placebo in ALS, turning this phenotypic drug discovery story from two undergrads into a post-mortem highlighting the importance of clearly defined molecular mechanisms of action. This article reviews what happened and what we can learn.