| Adbry | Biologics | tralokinumab-ldrm | To treat moderate-to-severe atopic dermatitis | | | 2021-12-27 | LEO PHARMA AS |
| Leqvio | NME | inclisiran | To treat heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease as an add-on therapy | | | 2021-12-22 | NOVARTIS |
| Vyvgart | Biologics | efgartigimod alfa-fcab | To treat generalized myasthenia gravis | Press Release | | 2021-12-17 | ARGENX BV |
| Tezspire | Biologics | tezepelumab-ekko | To treat severe asthma as an add-on maintenance therapy | | | 2021-12-17 | ASTRAZENECA AB |
| Cytalux | | pafolacianine | To help identify ovarian cancer lesions | Press Release | | 2021-11-29 | |
| Livtencity | NME | maribavir | To treat post-transplant cytomegalovirus (CMV) infection/disease that does not respond (with or without genetic mutations that cause resistance) to available antiviral treatment for CMV | Press Release | | 2021-11-23 | TAKEDA PHARMS USA |
| Voxzogo | NME | vosoritide | To improve growth in children five years of age and older with achondroplasia and open epiphyses | Press Release | | 2021-11-19 | BIOMARIN PHARM |
| Besremi | | ropeginterferon alfa-2b-njft | To treat polycythemia vera, a blood disease that causes the overproduction of red blood cells | Press Release | | 2021-11-12 | |
| Scemblix | | asciminib | To treat Philadelphia chromosome-positive chronic myeloid leukemia with disease that meets certain criteria | | | 2021-10-29 | |
| Tavneos | NME | avacopan | To treat severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis (granulomatosis with polyangiitis and microscopic polyangiitis) in combination with standard therapy, including gl | | | 2021-10-07 | CHEMOCENTRYX |
| Livmarli | NME | maralixibat | To treat cholestatic pruritus associated with Alagille syndrome | | | 2021-09-29 | MIRUM |
| Qulipta | NME | atogepant | To prevent episodic migraines | | | 2021-09-28 | ABBVIE INC |
| Tivdak | Biologics | tisotumab vedotin-tftv | To treat recurrent or metastatic cervical cancer with disease progression on or after chemotherapy | | | 2021-09-20 | SEAGEN |
| Exkivity | | mobocertinib | To treat locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations | | | 2021-09-15 | |
| Skytrofa | Biologics | lonapegsomatropin-tcgd | To treat short stature due to inadequate secretion of endogenous growth hormone | | | 2021-08-25 | ASCENDIS PHARMA ENCOCRINOLOGY DIV A/S |
| Korsuva | NME | difelikefalin | To treat moderate-to-severe pruritus associated with chronic kidney disease in certain populations | | | 2021-08-23 | CARA THERAPEUTICS INC |
| Welireg | NME | belzutifan | To treat von Hippel-Lindau disease under certain conditions | | | 2021-08-13 | MERCK SHARP DOHME |
| Nexviazyme | Biologics | avalglucosidase alfa-ngpt | To treat late-onset Pompe disease | Press Release | | 2021-08-06 | GENZYME CORP |
| Saphnelo | | anifrolumab-fnia | To treat moderate-to severe systemic lupus erythematousus along with standard therapy | | | 2021-07-30 | |
| Bylvay | NME | odevixibat | To treat pruritus | | | 2021-07-20 | ALBIREO PHARMA INC |
