FDA publishes a guidance on a bioanalytical method to validate biomarkers in drug and biological product applications.
FDA releases the form FDA-483 with seven observations from an inspection at the Windsor, CT-based SCA Pharmaceuticals outsourcing facility.
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...
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 ...
FDA grants AstraZeneca traditional approval for Calquence (acalabrutinib) with bendamustine and rituximab for adults with previously untreated mantle ...
CDRHs annual report says it granted marketing authorization to 120 novel devices in 2024, which was four less than the previous years record-setting 1...
