Company Product Description Indication Status
Alexion Pharmaceuticals Inc., of Boston Ultomiris (ravulizumab-cwvz) C5 complement inhibitor Paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome FDA approved a 100-mg/mL formulation, which will cut infusion times by approximately 60%
Avenue Therapeutics Inc., of New York I.V. tramadol Analgesic Acute pain FDA issued a complete response letter because it determined the drug wasn't safe for the intended population due to the potential for opioid stacking
Astrazeneca plc, of Cambridge, U.K. ChAd0x1-S Vaccine COVID-19 prophylaxis The Therapeutic Goods Administration in Australia grated a provisional determination making it eligible to apply for provisional registration
Celltrion Group, of Incheon, South Korea CT-P59 Monoclonal  antibody targeting SARS-CoV-2 COVID-19 prophylaxis in people who had contact with SARS-CoV-2-infected patients Korean Ministry of Food and Drug Safety approved the IND for a phase III study
Gannex Pharma Co. Ltd., of Shanghai, a unit of Ascletis Pharma Inc. ASC-42 Farnesoid X receptor agonist Nonalcoholic steatohepatitis indication FDA approved the IND
Immunomedics Inc., of Morris Plains, N.J. Trodelvy (sacituzumab govitecan-hziy) Antibody-drug conjugate targeting Trop-2 Glioblastoma FDA granted orphan drug designation
Oncopeptides AB, of Stockholm Melflufen (melphalan flufenamide) Peptide-drug conjugate targeting aminopeptidases Relapsed refractory multiple myeloma Company informed the EMA that it plans to submit an application for a conditional marketing authorization based on the phase II Horizon study
Oxular Ltd., of Oxford, U.K. OXU-003 Undisclosed Retinoblastoma FDA granted rare pediatric disease designation and orphan drug designation

Notes

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