Study on Hold
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
FDA Places Clinical Hold on Novavax’s COVID-19-Influenza Combination and Stand-Alone Influenza Vaccine Candidates Due to Rare Adverse Event
Novavax, FDA, COVID-19, Influenza, Vaccine, Clinical Hold, Motor Neuropathy
FDA Places Clinical Hold on Novavax’s COVID-19-Influenza Combination and Standalone Influenza Vaccine Trials
Novavax, FDA, Clinical Hold, COVID-19, Influenza, Vaccine Trials, Motor Neuropathy
FDA Halts Kezar’s Lupus Nephritis Trial Due to Safety Concerns Following Four Patient Deaths
FDA, Kezar Life Sciences, lupus nephritis, zetomipzomib, clinical hold, patient deaths, safety concerns
FDA Places Clinical Hold on vTv Therapeutics’ Diabetes Drug Program
vTv Therapeutics, diabetes drug, clinical hold, FDA, cadisegliatin, type 1 diabetes
RAPT Therapeutics Announces Significant Workforce Reduction Following Clinical Hold on Zelnecirnon Trials
RAPT Therapeutics, zelnecirnon, clinical hold, workforce reduction, FDA, clinical trials, atopic dermatitis, asthma, oncology, CCR4 agonist