Drug compounders sue over weight loss drugs’ removal from FDA shortage list
A trade group representing compounding pharmacies has filed a lawsuit against the Food and Drug Administration (FDA) for ...
Drug compounders sue US FDA over removal of Wegovy, Ozempic from shortage list
Drug compounders sued the U.S. Food and Drug Administration on Monday over its decision last week to remove Novo Nordisk's ...
BioPharma Dive1d
Mirum drug for rare genetic disease gains FDA approval
Mirum gained the drug, which it will sell as Ctexli for adults with cerebrotendinous xanthomatosis, in a 2023 deal with ...
Deal pays off for drugmaker with approval for rare cholesterol-related disease treatment
A young Peninsula drugmaker won regulatory approval Friday for a rare-disease drug picked up in a deal two years ago.
MedPage Today4d
FDA Approves First Drug for Rare Lipid Storage Disorder
Chenodiol -- a naturally occurring human bile acid also known as chenodeoxycholic acid -- is the first FDA-approved drug indicated for the rare lipid storage disease and autosomal recessive genetic ...