Anixa Biosciences assumes full sponsorship of a Cleveland Clinic IND for ian experimental breast cancer vaccine as it heads towards a Phase 2 clinica...
A new report from STAT describes drug review turmoil at FDA that led to FDA Oncology Center of Excellence director Richard Pazdur overriding CBER revi...
HHS acting general counsel Sean Keveney is appointed FDAs new chief counsel.
FDA grants Dyne Therapeutics a breakthrough therapy designation for DYNE-251 for treating patients with Duchenne muscular dystrophy that is amenable t...
FDA grants TransMedics Group conditional approval to begin its next-generation Organ Care System ENHANCE heart trial.
FDA approves Novo Nordisks Alhemo (concizumab-mtci) as a once-daily preventive treatment for bleeding episodes in patients 12 years and older with hem...
FDA issues Regeneron a second complete response letter on its BLA for odronextamab and its use in relapsed/refractory follicular lymphoma after citing...
Allogene Therapeutics modifies its ALPHA3 clinical trial for large B-cell lymphoma following the death of a patient attributed to its investigational ...
