Company Product Description Indication Status
Astrazeneca plc, of Cambridge, U.K. PT-010 Budesonide/glycopyrronium/formoterol fumarate Chronic obstructive pulmonary disease China National Medical Products Administration approved the triple-combination therapy in a pressurized metered-dose inhaler
Astrazeneca plc, of Cambridge, U.K., and Daiichi Sankyo Co. Ltd., of Tokyo Enhertu (fam-trastuzumab deruxtecan-nxki) Antibody-drug conjugate targeting HER2 Unresectable or metastatic HER2-positive breast cancer after 2 or more prior anti-HER2-based regimens in the metastatic setting FDA approved the drug
Beigene Ltd., of Beijing, and Bristol-Myers Squibb Co., of New York Revlimid (lenalidomide) Immunomodulatory agent Relapsed or refractory indolent lymphoma China National Medical Products Administration accepted the supplemental NDA
Biomarin Pharmaceutical Inc., of San Rafael, Calif. Valoctocogene roxaparvovec Gene therapy expressing factor VIII Hemophilia A Submitted BLA to the FDA
Eisai Inc., of Woodcliff Lake, N.J. Dayvigo (lemborexant) Blocks orexin receptor 1 and 2 Insomnia FDA approved the drug
Intra-Cellular Therapies Inc., of New York Caplyta (lumateperone) Antagonist of serotonin 5-HT2A receptor and dopamine D2 receptor Schizophrenia FDA approved the drug
Fibrogen Inc., of San Francisco Roxadustat HIF-PH inhibitor Anemia of chronic kidney disease Submitted NDA to the FDA
Seattle Genetics Inc., of Bothell, Wash. Tucatinib Tyrosine kinase inhibitor of HER2 Locally advanced unresectable or metastatic HER2-positive breast cancer after treatment with at least 3 prior HER2-directed agents Submitted NDA to the FDA
Viiv Healthcare Ltd., of London Cabotegravir and rilpivirine Integrase inhibitor and non-nucleoside reverse transcriptase inhibitor HIV-1 infection in virologically suppressed adults FDA issued a complete response letter related to chemistry, manufacturing and controls

Notes

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

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