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.
The U.S. FDA lifted a clinical hold on a trial testing Concert Pharmaceuticals Inc.’s therapy for alopecia areata, a type of hair loss.
The U.S. FDA placed a hold on Seattle Genetics’ Investigational New Drug Application for vadastuximab talirine.
Concert Pharmaceuticals Inc. said the U.S. FDA imposed a clinical hold on a trial testing the company’s drug to treat alopecia areata, a type of hair loss.