Tag

Clinical Hold

All articles tagged with #clinical hold

healthcare2 years ago•0 min saved

FDA Imposes Partial Hold on Gilead's Magrolimab Trials for AML

The FDA has placed a partial clinical hold on Gilead's magrolimab, a CD47 candidate for acute myeloid leukemia (AML). Gilead has halted the screening and enrollment of new patients in US trials studying the drug in AML, but patients already enrolled can continue treatment. The hold affects two Phase III studies, ENHANCE-2 and ENHANCE-3, as well as Gilead's expanded access program.

via Endpoints News|

#acute-myeloid-leukemia #clinical-hold #fda

clinical-trials2 years ago•6 min saved

FDA imposes partial hold on Gossamer lymphoma drug trial after patient deaths.

The FDA has placed a partial clinical hold on Gossamer Bio's Phase Ib/II study of its BTK inhibitor for central nervous system lymphoma after two patient deaths occurred in the trial. The hold was placed due to serious adverse events, including atrial fibrillation, a sudden death event, and a fatal intracranial hemorrhage. Gossamer Bio had previously paused the trial due to a "benefit/risk profile."

via Endpoints News|

#clinical-hold #clinical-trials #fda