Company Product Description Indication Status
Actinogen Medical Ltd., of Sydney Xanamem Blocks production of intracellular cortisol Fragile X syndrome FDA granted rare pediatric disease designation
Bristol Myers Squibb Co., of New York Breyanzi (lisocabtagene maraleucel)  Anti-CD19 CAR T therapy Relapsed or refractory large B-cell lymphoma Approved by FDA for use in patients who have received at least 2 prior therapies
Celltrion Group, of Incheon, Korea Regdanvimab (CT-P59) Anti-COVID-19 monoclonal antibody COVID-19 Korean Ministry of Food and Drug Safety granted conditional marketing authorization for emergency use to treat adults who are 60 or older or who have at least 1 underlying medical condition with mild symptoms of COVID-19, and adults with moderate symptoms of COVID-19
Innocare Pharma Ltd., of Beijing Orelabrutinib BTK inhibitor Mantle cell lymphoma China’s NMPA approved the phase III trial testing combination with R-CHOP for previously untreated patients; primary endpoint is progression-free survival
Johnson & Johnson, of New Brunswick, N.J. JNJ-78436735 (single-dose COVID-19 vaccine) SARS-CoV-2 recombinant adenoviral vector vaccine COVID-19 Submitted request to FDA seeking emergency use authorization based on top-line data from phase III Ensemble trial
Novavax Inc., of Gaithersburg, Md. NVX-CoV2373 COVID-19 spike glycoprotein modulator COVID-19 Started rolling review process for authorization with multiple regulatory agencies, including FDA, EMA, U.K.’s MHRA and Health Canada; firm is completing pivotal phase III trials in U.K. and U.S.
Russian Direct Investment Fund, of Moscow Sputnik V Vaccine; COVID-19 spike glycoprotein modulator COVID-19 Vaccine registered by Ministry of Health of Lebanon; approved under emergency use authorization procedure
TG Therapeutics Inc., of New York Ukoniq (umbralisib) Oral PI3K delta and CK1 epsilon inhibitor Marginal zone lymphoma and follicular lymphoma Granted accelerated approval by FDA for use in adults with relapsed or refractory MZL who have received at least 1 prior anti-CD20-based regimen and for treating adults with relapsed or refractory FL who have received at least 3 prior lines of therapy


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