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AstraZeneca/Daiichi's Flagship Drug Enhertu Secures Accelerated FDA Approval For Pretreated Cancer Patients With Solid Tumor

On Friday, the FDA approved Daiichi Sankyo Ltd’s (OTC:DSKYF) (OTC:DSNKY) and AstraZeneca Plc’s (NASDAQ:AZN) Enhertu (fam-trastuzumab deruxtecan-nxki) for unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR). Continued approval for this indicat ....

Ken Keller , Wikimedia Commons , Daiichi Sankyo Ltd , Daiichi Sankyo Inc , Astrazeneca Plc , New Hope , Aggressive Lung Cancer , Imfinzi Shows Promising Results , Global Head , Oncology Business , Daiichi Sankyo , Stock Market Game , Benzinga Pro , Day Trial , Flagship Drug Enhertu Secures Accelerated ,

First Amended Complaint in Esperion Therapeutics, Inc. v. Daiichi Sankyo Europe GmbH, Case No. 1:23-cv-02568-ER - Form 8-K

Case 1:23-cv-02568-ER Document 19 Filed 05/04/23 Page 1 of 37

Plaintiff Esperion Therapeutics, Inc. , by its attorneys, Gibson, Dunn &. | May 4, 2023 ....

Ann Arbor , United States , New York , Rodney Smith , Daiichi Sankyo Europe , Benoit Creveau , Matt Benjamin , Patricia Vanston , Philipp Hoffman , Benjamin Looker , Stefan Seyfried , Europe Jan , Joanne Foody , Daiichi Sankyo Europe Gmb , Sheldon Koenig , Daiichi Sankyo , Andreas Berger , Van Ruymbeke , Orin Snyder , Wolfgang Schiessl , Mary Beth Maloney , Steven Nissen , Sankyo Europe , Jan Van , Daiichi Sankyo Inc , European Medicines Agency ,