U.S. regulators halted a trial of Novartis’ Zolgensma treatment after an animal study raised safety concerns, in a setback for the drugmaker’s plan to expand the product’s use to older patients.
The U.S. Food and Drug Administration lifted a partial clinical hold placed on AbbVie’s Phase III CANOVA trial evaluating venetoclax for the treatment of relapsed/refractory multiple myeloma.
The U.S. Food and Drug Administration placed a partial clinical hold on all trials of AbbVie’s Venclexta for multiple myeloma, after a review of data found a higher proportion of deaths in the cancer drug arm of the late-stage study.
The U.S. Food and Drug Administration placed Princeton, N.J.-based Advaxis’ Phase III clinical trial of axalimogene filolisbac (AXAL) in advanced cervical cancer on partial clinical hold.
The U.S. Food and Drug Administration placed a clinical hold on an Investigational New Drug Application (IND) for Translate Bio’s rare liver disease treatment asset, MRT5201.
Capricor Therapeutics Inc. put on hold a clinical trial of the company’s experimental drug to treat Duchenne muscular dystrophy (DMD), a muscle-wasting disorder, citing a safety review.
The U.S. Food and Drug Administration lifted a clinical hold and accepted an Investigational New Drug Application (IND) for an experimental sickle cell disease treatment being jointly developed by Vertex Pharmaceuticals and CRISPR Therapeutics.
Mersana Therapeutics Inc. announced that the U.S. Food and Drug Administration lifted the partial clinical hold on the Phase 1 study of the experimental cancer drug XMT-1522.
Two Roche drugs were placed on partial clinical hold as the U.S. FDA continues to examine potential dangers of checkpoint inhibitors following deaths associated with Merck’s Keytruda.
CEL-SCI received a letter from the U.S. FDA stating that the clinical hold that had been imposed on the company’s Phase 3 cancer study with Multikine was removed.