Though Arcellx’s Phase 2 test is under a clinical hold, the FDA cleared Arcellx to dose patients who have already undergone lymphodepletion, the step in which most of a patient’s immune cells ...

Sarepta Therapeutics lays off 493 workers amid FDA probe, stock drop, and concerns over its gene therapy treatment, Elevidys.

PepGen Inc., a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological ...

The clinical hold was initiated after the occurrence of Serious Adverse Events (SAEs) in three patients, which included a death in the ALL study and two life-threatening events in the NHL study.

The FDA has lifted one of the two clinical holds placed on Kezar Life Sciences’ zetomipzomib, leading the biotech to speculate on whether to reignite another program for the same drug that remains ...

--Fulcrum Therapeutics, Inc. ®, a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases, today announced that the U.S. Food ...

FDA removed the clinical hold following the agency’s review of Gilead’s comprehensive plan and corresponding data on the storage and compatibility of lenacapavir injection with an alternative ...

Kezar Life Sciences said a partial clinical hold on a trial for its zetomipzomib program to treat autoimmune hepatitis has been lifted by the Food and Drug Administration. The FDA lifted the hold ...

The FDA had placed a clinical hold on the study late last year following a patient death. By Frank Vinluan on April 28, 2022 11:57 am. Share. Share Options. Share a link too this article.

CAMBRIDGE, Mass., Oct. 31, 2023 (GLOBE NEWSWIRE) -- Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of ...

Vigil Neuroscience (NASDAQ:VIGL) announced Tuesday that the U.S. Food and Drug Administration (FDA) has removed the partial clinical hold on its ongoing Phase 1 clinical trial for its Alzheimer ...

Allogene's (ALLO) Phase 2 ALPHA 2 trial was put on a clinical hold three months ago. Despite the risk, read more to see why I will continue to buy ALLO stock.