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Autolus Announces Acceptance Of MAA By EMA For Obe-cel For Patients With Adult R/r B-cell ALL

By RTTNews Staff Writer   ✉  | Published:  | Google News Follow Us  | Join Us
rttnewslogo20mar2024

Tuesday, Autolus Therapeutics plc. (AUTL) announced that the European Medicines Agency has accepted the Company's Marketing Authorization Application for obecabtagene autoleucel also known as obe-cel to treat patients with relapsed/refractory adult B-cell Acute Lymphoblastic Leukemia or ALL.

The MAA submission was based on data from the pivotal Phase 2 FELIX study of obe-cel in adult r/r B-cell ALL.

Additionally, the company mentioned that the US marketing application is currently under review with a Prescription Drug User Fee Act target action date set for November 16, 2024.

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Business News

Global Economics Weekly Update -June 15 - June 19, 2026

June 19, 2026 16:46 ET
Major central banks continued to dominate the economic news flow this week too, led by the Federal Reserve, as they announced their latest policy decisions. The Federal Reserve policy session was in focus as it was the first to be led by the new chief Kevin Warsh. In Europe, central banks of the U.K. and Switzerland announced their rate decisions. In Asia, the Bank of Japan drew attention for its policy moves, while data out of China threw some light on the state of the economy.