FDA Approves Imcivree for Rare Genetic Obesity Disorders
The FDA has approved Imcivree™ (setmelanotide; Rhythm Pharmaceuticals) for chronic weight management in patients with obesity due to POMC, PCSK1, or LEPR deficiency.
All articles by Brian Park, PharmD
Microbiome-Derived Therapy Gets Orphan Drug Status for Hepatocellular Carcinoma
The Food and Drug Administration (FDA) has granted Orphan Drug designation to SFA001 (SFA Therapeutics) for the treatment of hepatocellular carcinoma (HCC).
Investigational Farnesoid X Receptor Agonist Gets Fast Track Status for NASH
The FDA has granted Fast Track designation to TERN-101 (Terns Pharmaceuticals) for the treatment of non-alcoholic steatohepatitis.
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