|Jemincare Group, of Shanghai||JMB-2002||Anti-SARS-CoV-2 neutralizing antibody||COVID-19||Cleared by FDA for clinical trial|
|Kite, of Santa Monica, Calif., a Gilead Co.||Tecartus (brexucabtagene autoleucel)||Autologous anti-CD19 CAR T therapy||Relapsed or refractory B-cell precursor acute lymphoblastic leukemia||Submitted supplemental BLA to the FDA|
|Moderna Inc., of Cambridge, Mass.||Moderna COVID-19 Vaccine||COVID-19 spike glycoprotein modulator||COVID-19||FDA updated label to authorize vaccine to be kept at room temperature conditions once removed from refrigerator for administration for 24 hours, an increase from previous 12 hours; a punctured vial is now useable for up to 12 hours, an increase from previous 6 hours; FDA also authorized inclusion of a new vial presentation with a maximum of 15 doses and authorized a maximum of 11 doses of vaccine in the current format, from the previously authorized 10 doses per vial|
|Ose Immunotherapeutics SA, of Nantes, France||Covepit||Protein subunit vaccine||COVID-19||Belgian Federal Agency for Medicines and Health Products and Belgian Ethics Committee approved phase I trial testing vaccine in 48 healthy volunteers; first subjects to be enrolled shortly|
|Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y.||Praluent (alirocumab)||Anti-PCSK9 antibody||Homozygous familial hypercholesterolemia||Approved by FDA for use when added to other treatments for HoFH|
|Tetra Bio-Pharma Inc., of Ottawa, Ontario||Reduvo softgel capsules||Cannabinoid||Undisclosed||Received notice of compliance for its drug establishment license following audit by Drug GMP Inspection Program of Health Canada|
For more information about individual companies and/or products, see Cortellis.