Opzelura (ruxolitinib) / Incyte | Atopic dermatitis | 9/21/2921 FDA approves this small-molecule JAK/STAT inhibitor formulated as a cream |
Tivdak (tisotumab vedotin-tftv) / Seagen | Cervical cancer | 9/20/2021 FDA grants accelerated approval to this human tissue factor IgG1κ mAb targeting tissue factor conjugated to MMAE via a protease-cleavable linker |
Exkivity (mobocertinib) / Takeda | Non-small-cell lung cancer | 9/15/2021 FDA grants accelerated approval to this small-molecule selective tyrosine kinase inhibitor targeting EGFR and human EGFR2 exon insertion 2 |
Voxzogo (vosoritide) / BioMarin | Achondroplasia | 8/27/2021 EMA approves this stabilized 39-residue analog of C-type natriuretic peptide containing 17 extra amino acids (PGQEHPNARKYKGANKK) appended to the native hormone’s N terminus |
Bimzelx (bimekizumab) / UCB | Psoriasis | 8/24/2021 EMA approved this humanized bispecific IgG1 mAb that neutralizes both IL-17A and IL-17F |
Korsuva (difelikefalin) / Cara Therapeutics | Pruritus | 8/23/2021 FDA approves this small-molecule κ-opioid receptor agonist |
Evrenzo (roxadustat) / AstraZeneca | Anemia due to chronic renal failure | 8/19/2021 EMA approves this second-generation hypoxia-inducible factor prolyl hydroxylase inhibitor |
Nexviazyme (avalglucosidase alfa-ngpt) / Sanofi | Pompe disease | 8/6/2021 FDA approves this α-glucosidase enzyme replacement therapy targeting mannose-6-phophate receptor to facilitate cellular uptake |
Saphnelo (anifrolumab- fnia) / AstraZeneca | Systemic lupus erythematosus | 7/30/2021 FDA approves this fully human IgG1 mAb targeting interferon-α receptor 1 |
Skysona (Lenti-D, (elivaldogene autotemcel) / Bluebird Bio | Cerebral adrenoleukodystrophy | 7/21/2021 EMA approves these autologous hematopoietic CD34+ stem cells transduced with a lentiviral vector encoding human ABCD1 cDNA under the control of a modified enhancer/promoter of myeloproliferative sarcoma virus |
Bylvay (odevixibat) / Albireo Pharma | Progressive familial intrahepatic cholestasis | 7/20/2021, 7/19/2021 FDA and EMA approve this small-molecule inhibitor of ileal bile acid transporter |
Rezurock (belumosudil) / Kadmon Holdings | Graft versus host disease treatment | 7/16/2021 FDA approves under its real-time approval review process this small-molecule selective oral inhibitor of Rho-associated coiled-coil kinase 2 (ROCK2) involved in inflammatory responses |
Zy-CoV-D / Zydus Cadila | COVID-19 prevention | 8/20/2021 India’s Drugs Controller General grants an EUA to this DNA vaccine encoding the spike glycoprotein of SARS-CoV-2 and IgE signal peptide delivered intradermally via the PharmaJet Tropis ID fluid-stream injection device |
