https://www.biopharmadive.com/news/fda-rejects-akebia-anemia-drug-vadadustat/621304/
FDA rejects Akebia drug, dealing another blow to anemia pills | BioPharma Dive
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https://www.healio.com/news/endocrinology/20251231/fda-declines-to-approve-relacorilant-for-hypertension-linked-to-hypercortisolism
FDA rejects relacorilant for hypertension tied to Cushing’s
The FDA has issued a complete response letter for an oral selective glucocorticoid receptor antagonist under investigation for the treatment of hypertension...
fda rejectshypertensiontied
https://www.biopharmadive.com/news/fda-reject-ultragenyx-gene-therapy-complete-response/752920/
FDA rejects Ultragenyx gene therapy over manufacturing concerns | BioPharma Dive
While the CRL derails a near-term clearance, one analyst described the rejection as more of “a speed bump to approval, rather than a roadblock.”
fda rejectsgene therapydive