Company Product Description Indication Status
Autolus Therapeutics plc, of London AUTO-1 CAR T targeting CD19 Relapsed/refractory B-acute lymphocytic leukemia EMA granted priority medicines designation
Beyondspring Inc., of New York Plinabulin  Selective immune-modulating microtubule-binding agent Chemotherapy-induced neutropenia Submitted NDAs to the FDA and the China National Medical Products Administration for use of plinabulin plus granulocyte colony-stimulating factor
Lannett Co. Inc., of Philadelphia, and Respirent Pharmaceuticals Co. Ltd., of Chongqing, China Fluticasone propionate and salmeterol inhalation powder Generic to Advair Diskus (Glaxosmithkline plc) Asthma and chronic obstructive pulmonary disease Submitted ANDA 
Moderna Inc., of Cambridge, Mass. COVID-19 Vaccine Moderna mRNA-based vaccine COVID-19 prophylaxis U.K. regulators granted conditional marketing authorization
Neurophth Biotechnology Ltd., of Wuhan, China NR-082   Gene therapy expressing ND4 Leber hereditary optic neuropathy Center for Drug Evaluation of China National Medical Products Administration approved the IND
Sanofi SA, of Paris Sarclisa (isatuximab-irfc) Monoclonal antibody targeting an epitope on the CD38 receptor on multiple myeloma cells Relapsed or refractory multiple myeloma FDA approved the expanded indication for the drug in combination with carfilzomib and dexamethasone in patients after 1-3 lines of prior therapy
Secura Bio Inc., of Summerlin, Nev. Copiktra (duvelisib) Phosphoinositide 3-kinase inhibitor Relapsed or refractory chronic lymphocytic leukemia  EMA’s Committee for Medicinal Products for Human Use adopted a positive opinion for use in CLL after at least 2 prior therapies and FL that is refractory to at least 2 prior systemic therapies
Taiho Oncology Inc., of Princeton, N.J. Futibatinib (TAS-120) Covalently-binding FGFR inhibitor Previously treated locally advanced or metastatic cholangiocarcinoma harboring FGFR2 gene rearrangements FDA granted breakthrough therapy designation
United Therapeutics Corp., of Silver Spring, Md. Tyvaso (treprostinil) Dilates blood vessels Pulmonary hypertension associated with interstitial lung disease  FDA approved the expanded indication

Notes

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