The latest drug approval news involving applications, processes, and reviews of new medicines.
It’s been a busy year for the FDA, and despite ongoing turmoil within the agency, many approval decisions appear to be proceeding as normal. According to data firm Citeline’s Biomedtracker, the FDA is on track to deliver roughly 70 approvals and label expansions in 2024. That number includes several new cancer drugs, along with first-in-class treatments for rare diseases such as a septic shock vaccine and an anti-aging drug. The FDA also has approved a combination treatment for a certain type of lung cancer and a gene therapy that reduces the risk of heart attacks and strokes. In other big approval news, Bristol Myers Squibb won accelerated approval for a therapy that targets the mIDH1/2 mutations that drive glioblastomas. And Ultragenyx Pharmaceuticals is seeking accelerated approval for UX111, which treats Sanfilippo syndrome type A with cerebrospinal fluid heparan sulfate.