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 ...

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 ...

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

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

--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 ...

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 ...

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 ...

Earlier this year, BioNTech’s partner MediLink Therapeutics (Suzhou) Co., Ltd said the FDA placed a partial clinical hold on the Phase 1 trial of BNT326/YL202 as a later-line treatment in ...

Amylyx Pharmaceuticals said the Food and Drug Administration had lifted its clinical hold on a trial of the company's treatment for patients with ALS. The Cambridge, Mass., company is now working ...

The FDA has lifted a clinical hold on three programs being developed by CARsgen Therapeutics. Congressional Quarterly. By Zac Ezzone – Staff writer, Triangle Business Journal. Nov 4, 2024.