Drug Approval | July 10, 2023
Astellas receives FDA priority review for Zolbetuximab biologics license application
Astellas stands on the forefront of healthcare change to turn innovative science into value for patients
Astellas stands on the forefront of healthcare change to turn innovative science into value for patients
This action follows the recent acceptance of the Marketing Authorization Application (MAA) for Pfizer’s RSV vaccine candidate by the European Medicines Agency
FDA also accepts a separate supplemental application to extend prophylaxis with PREVYMIS to 200 days in certain HSCT recipients
If approved, TAK-003 has the potential to become an important dengue prevention option for healthcare providers
This is the third major regulatory milestone for the vaccine candidate following acceptance of regulatory submissions in Europe and Japan
Submission based on QuANTUM-First results showing quizartinib plus chemotherapy significantly improved overall survival compared to chemotherapy alone
Orelabrutinib is a highly selective BTK inhibitor developed by InnoCare for the treatment of cancers and autoimmune diseases.
Dupixent would be the first and only medicine specifically indicated to treat prurigo nodularis in the U.S., if approved
If approved, it will be the first USFDA-approved immunomodulator for the treatment of Covid-19 in hospitalised patients
If approved, Opdivo plus chemotherapy would be the first neoadjuvant immunotherapy-based option for patients with resectable non-small cell lung cancer in the U.S.
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