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

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 ...

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 ...

--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 ...

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 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.

Vyne Therapeutics has given up hopes of resuming a plaque psoriasis trial for its BET inhibitor placed on hold by the FDA, ...

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 ...

Neurizon Therapeutics has announced progress to lift a US Food and Drug Administration (FDA) clinical hold on its lead drug .

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 ...

The clinical hold means that Bala Cynwyd, Pennsylvania-based Larimar can’t proceed with further tests of the drug, CTI-1601, in humans, ...

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.