The FDA has approved Dojolvi™ (triheptanoin; Ultragenyx) as a source of calories and fatty acids for the treatment of pediatric and adult patients with molecularly confirmed long-chain fatty acid oxidation disorders.
Agency now says risk among adults increases steadily with age, and is not limited to those over 65.
The FDA has accepted for Priority Review the New Drug Application for lumasiran for the treatment of primary hyperoxaluria type 1.
Statistical models suggest phentermine, topiramate, combination can slow, prevent weight regain
The FDA has accepted for Priority Review the New Drug Application (NDA) for lonafarnib (Zokinvy™; Eiger BioPharmaceuticals) for the treatment of progeria and progeroid laminopathies, rare, genetic conditions of accelerated aging in children.
Sociodemographic risk factors include male sex, deprivation, population density, ethnicity, obesity.
The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for setmelanotide for the treatment of pro-opiomelanocortin (POMC) deficiency obesity and leptin receptor (LEPR) deficiency obesity.
Post-approval study results on the risk of hyperinflation, acute pancreatitis, and death associated with the use of liquid-filled intragastric balloons have been made available by the FDA.
Horizon Therapeutics announced the availability of Procysbi (cysteamine bitartrate) delayed-release oral granules in tear-open packets for the treatment of nephropathic cystinosis in patients aged 1 year and older.
Second study shows obesity is one of the most important factors for admission.
