President Donald Trump orders all government departments and agencies like FDA to end work-from-home arrangements and head back to the office as soon ...
FDA accepts for priority review a Replimune Group BLA for RP1 (vusolimogene oderparepvec) in combination with nivolumab for patients with advanced mel...
FDA lifts a clinical hold on an Amylyx Pharmaceuticals Phase 1 clinical trial of AMX0114, an investigational antisense oligonucleotide for treating am...
Federal Register notice: FDA amends its regulations to reflect recent application-related actions for new animal drug applications and abbreviated new...
FDA approves Amgens Lumakras (sotorasib) for use with its Vectibix (panitumumab) for adult patients with KRAS G12C-mutated metastatic colorectal cance...
CDER posts its latest guidance agenda that shows it is committing to issuing 11 drug quality guidance documents in 2025.
An FDA update says contrary to an earlier alert, all new neonatal incubators currently supplied in the U.S. do not show concerning levels of airborne ...
