FDA approves relacorilant with nab-paclitaxel for platinum-resistant
On March 25, 2026, the Food and Drug Administration approved relacorilant (Lifyorli, Corcept Therapeutics Inc.), a glucocorticoid receptor antagonist, in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian...Guidance Recap Podcast
PodcastThank you for joining us for another episode of the Guidance Recap Podcast. The Guidance Recap Podcast provides highlights for FDA guidance documents straight from the authors. My name is Kylie Haskins, and I am the host for today’s podcast. In today’s episode,...FDA Approves Drug to Treat Neurologic Manifestations of Hunter Syndrome
For Immediate Release: March 25, 2026 The U.S. Food and Drug Administration approved Avlayah (tividenofusp alfa-eknm) to treat certain individuals with Hunter syndrome (Mucopolysaccharidosis type II or MPS II). “Today is a milestone day for children and their...General Biologics Guidances
Guidance documents describe FDA’s interpretation of our policy on a regulatory issue (21 CFR 10.115(b)). These documents usually discuss more specific products or issues that relate to the design, production, labeling, promotion, manufacturing, and testing of...All Drug Purchases Are
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