|Aruvant Sciences Holdings Ltd., of London||ARU-1801||HBG gene stimulator||Sickle cell disease||EMA granted priority medicines designation|
|Asana Biosciences LLC, of Lawrenceville, N.J.||Gusacitinib (ASN-002)||Janus kinase and spleen tyrosine kinase inhibitor||Moderate to severe chronic hand eczema||FDA granted fast track designation|
|Biocryst Pharmaceuticals Inc., of Research Triangle Park, N.C.||Rapivab (peramivir)||Cyclopentane analogue||Acute uncomplicated influenza||FDA approved the supplemental NDA, lowering the approved age to children 6 months and older|
|Innovent Biologics Inc., of San Francisco, and Indianapolis-based Eli Lilly and Co.||Tyvyt (sintilimab)||Monoclonal antibody targeting PD-1||Nonsquamous non-small-cell lung cancer||National Medical Products Administration of China approved the supplemental NDA for use of the drug in combination with pemetrexed and platinum chemotherapy in the first-line setting|
|Prothena Corp. plc, of Dublin||Birtamimab||Serum amyloid A protein inhibitor; amyloid protein deposition inhibitor||AL amyloidosis||Following discussions with FDA, advancing into confirmatory phase III Affirm-AL study, to be conducted with a primary endpoint of all-cause mortality at p<0.10 under a special protocol assessment agreement|
|Russian Direct Investment Fund, of Moscow||Sputnik V||Adenoviral vector-based vaccine||COVID-19 prophylaxis||Federal Commission for the Protection against Sanitary Risk of Mexico approved the vaccine under the emergency use authorization procedure|
|Russian Direct Investment Fund, of Moscow||Sputnik V||Adenoviral vector-based vaccine||COVID-19 prophylaxis||Ministry of Health of the Republic of Nicaragua approved the vaccine under the emergency use authorization procedure|
For more information about individual companies and/or products, see Cortellis.