The 2021 New Drug Approvals for Immunological Diseases: Deep Dive

Recently, we summarized the novel small molecule drug approvals of 2023 (34/55). The remaining 21 molecular entities approved were large molecules like proteins and oligonucleotides, accounting for nearly 38% of the total approvals. Notably, seven of these large molecules have earned the prestigious Breakthrough Therapy designation, relative to the two small molecules that share this recognition. A summary of approvals for large molecule drugs, accompanied by links to FDA labels and additional information pertaining to the drug's discovery and originators, appears here.

Here’s a rundown of August’s key clinical developments, including FDA approvals, potential upcoming approvals, notable trial readouts, new NDA submissions, and pipeline realignments.

There continue to be opportunities for another KRAS(G12C) inhibitor to prove itself best-in-class.

This roundup highlights twelve KRAS(G12C) molecules to know, with links to recent case studies on Drug Hunter going in more detail.

This article compiles 20+ recent small molecules of general interest in the news in April 2023, with structures where they are available. Capacity Bio’s MAS Receptor Agonists with $35M Raised for FIH Clinical Trials MAS modulator from WO2022165189 example 107 New start-up Capacity Bio backed by RA Capital, Insight Partners, and Remiges [...]

While gadolinium-based MRI contrast agents (GBCAs) are important for enhancing MRI and MRA imaging, several studies have shown that gadolinium can be retained in the brain and body for months to years after GBCA injection, prompting the FDA to issue box warnings to the drug class. Gadopiclenol, the ninth approved GBCA, was designed to enable use of a lower gadolinium dose than other agents. This highlight reviews how it works and why it’s notable.