clinical hold

Patient death prompts clinical trial pause for Kura Oncology leukemia drug

The FDA placed a partial clinical hold on a Kura Oncology leukemia drug following the death of one patient in the early-stage study. Kura executives said the death may be related to differentiation syndrome, a known complication of leukemia therapies.

The US FDA Lifts the Clinical Hold of Protagonist’s Rusfertide Clinical Development Program

Shots: The US FDA has lifted the clinical hold on the rusfertide development program & allow to resume patient dosing in clinical studies of rusfertide The company provides the information to the FDA on the basis of complete response & also give patient clinical safety reports & update the investigator brochure, patient informed consent forms, …

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Allogene Reports the US FDA’s Clinical Hold on ALPHA2 Study of ALLO-501A to Treat Large B Cell Lymphoma

Shots: The US FDA has placed a clinical hold on the ALPHA2 study that evaluates ALLO-501A CAR T in 100+ patients with large B-cell lymphoma The discontinuation is due to the observation of chromosomal abnormality in ALLO-501A CAR T cells which was detected in a bone marrow biopsy to test the patient with low blood …

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Second FDA clinical hold for Aprea cancer drug cites safety data in another study

For the second time in a week, the FDA placed a clinical hold on an Aprea Therapeutics cancer drug. The biotech said the agency cited safety and efficacy data from a prior failed clinical trial that tested the small molecule in a different form of cancer.