Keeping Track: Enhertu, Nubeqa Grow With RTOR; Interchangeable Cimerli And Another Nuplazid CRL

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

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The FDA topped off last week with two approvals under its popular Real-Time Oncology Review (RTOR) program, granting new indications to AstraZeneca PLC/Daiichi Sankyo Co., Ltd.’s Enhertu in HER2-low breast cancer and Bayer AG/Orion Corporation’s Nubeqa in hormone-sensitive prostate cancer.

While both approvals came in advance of the user fee goal date, the two-month review of the new Enhertu indication...

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