Study on Hold
FDA puts BioNTechs malaria vaccine on clinical hold
United States Food and Drug Administration, Malaria, Study on Hold, Vaccines, BioNTech ‘s, Clinical Trials
FDA Pauses BioNTech’s Malaria Vaccine Trial Amid Regulatory Scrutiny
BioNTech, malaria vaccine, FDA clinical hold, RNA vaccine, regulatory challenges
Atara Biotherapeutics Halves Workforce Amid FDA Setbacks for Key Therapies
Atara Biotherapeutics, layoffs, FDA clinical hold, Ebvallo, ATA3219, manufacturing issues
FDA Lifts Clinical Hold on Entrada’s Duchenne Muscular Dystrophy Drug ENTR-601-44 After Two Years
Duchenne muscular dystrophy, ENTR-601-44, Entrada Therapeutics, FDA, clinical hold, exon 44 skipping, ELEVATE-44-102, Phase 1b trial
FDA Halts Amgen’s Phase 1 Obesity Drug Trial: AMG 513 Study on Hold
Amgen, obesity drug, AMG 513, FDA clinical hold, Phase 1 trial, pharmaceutical setback
FDA Places Clinical Hold on Atara Biotherapeutics’ EBVALLO and ATA3219 Due to Manufacturing Compliance Issues
Atara Biotherapeutics, FDA clinical hold, EBVALLO, ATA3219, allogeneic T-cell therapies, manufacturing compliance issues, GMP compliance, Epstein-Barr virus, post-transplant lymphoproliferative disease, non-Hodgkin’s lymphoma, systemic lupus erythematosus.
Atara Biotherapeutics Faces Clinical Hold on EBVALLO and Pipeline Candidate Due to Manufacturing Site Inspection Issues
Atara Biotherapeutics, EBVALLO, Clinical Hold, FDA, Manufacturing Site Inspection, Cell Therapy, T-Cell Immunotherapy
FDA Places Clinical Hold on PepGen’s Duchenne Muscular Dystrophy Trial
FDA, Clinical Hold, PepGen, Duchenne Muscular Dystrophy, PGN-EDO51, CONNECT2-EDO51
FDA Issues Second Clinical Hold on Kezar’s Zetomipzomib Program Within Two Months
Kezar Life Sciences, Zetomipzomib, FDA Clinical Hold, Lupus Nephritis, Autoimmune Hepatitis, Clinical Trials
FDA Places Partial Clinical Hold on BioNTech’s Anti-CTLA-4 Antibody Trial
BioNTech, FDA, partial clinical hold, anti-CTLA-4 antibody, clinical trial, OncoC4