Company Product Description Indication Status
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

Notes

For more information about individual companies and/or products, see Cortellis.