Diabetes Bexagliflozine Dapagliflozine IND Dasiglucagon Exenatide Diabetes type 2 Extension of indication to include the treatment of type 2 diabetes in adolescents and children aged 10 years and above IND Finerenon Polyethylene glycol loxenatide Reparixin Sotagliflozine IND Teplizumab Tirzepatide Liver diseases Cenicriviroc Givosiran Maralixibat Progressive Familial Intrahepatic Cholestasis Type 2 Treatment of Progressive Familial Intrahepatic Cholestasis Type 2 Treatment of cholestatic liver disease in patients with Alagille syndrome (ALGS) 1 year of age and older. IND Obeticholic acid Odevixibat Seladelpar Metabolic diseases Arimoclomol Autologous CD34+ cell enriched population that contains hematopoietic stem and progenitor cells transduced ex vivo using a lentiviral vector encoding the human arylsulfatase A gene Avalglucosidase alfa Bardoxolone Methyl Betaine G Cipaglucosidase alfa / Miglustat Elamipretide Elivaldogene autotemcel Fexapotide Fosdenopterin Hydrocortison Kaliumcitraat / kaliumwaterstofcarbonaat Leriglitazone Levoketoconazole Liraglutide IND Lonafarnib Migalastat IND Octreotide Olenasufligene relduparvovec Olipudase alfa Palovarotene Pegunigalsidase alfa Pegvaliase Reloxaliase Sapropterin G Somatrogon Sparsentan Tenapanor IND Trientine Triheptanoin Veverimer Other metabolism and Endocrinology Burosumab IND Corifollitropin alfa IND Dapagliflozine IND Diazoxide choline (controlled-release tablet) Drospirenon / estetrol, monohydraat Empagliflozine IND Levonorgestrel G Linzagolix Lonapegsomatropin Lumasiran Osilodrostat Ospemifene Relugolix IND Relugolix / estradiol / norethisteronen Semaglutide IND Setmelanotide Imcivree is indicated for the treatment of obesity and the control of hunger associated with genetically confirmed loss-of-function biallelic pro-opiomelanocortin (POMC), including PCSK1, deficiency or biallelic leptin receptor (LEPR) deficiency in adults and children 6 years of age and above. Treatment of obesity and the control of hunger associated with genetically confirmed Bardet-Biedl syndrome (BBS). IND Sofpironium bromide Somapacitan Spheroids of human autologous matrix-associated chondrocytes IND Vosoritide