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FDA publishes a guidance on a bioanalytical method to validate biomarkers in drug and biological product applications.[ Price : $8.95]
FDA releases the form FDA-483 with seven observations from an inspection at the Windsor, CT-based SCA Pharmaceuticals outsourcing ...[ Price : $8.95]
President Donald Trump orders all government departments and agencies like FDA to end work-from-home arrangements and head back to...[ Price : $8.95]
FDA accepts for priority review a Replimune Group BLA for RP1 (vusolimogene oderparepvec) in combination with nivolumab for patien...[ Price : $8.95]
FDA lifts a clinical hold on an Amylyx Pharmaceuticals Phase 1 clinical trial of AMX0114, an investigational antisense oligonucleo...[ Price : $8.95]
An FDA update says contrary to an earlier alert, all new neonatal incubators currently supplied in the U.S. do not show concerning...[ Price : $8.95]
FDA grants AstraZeneca traditional approval for Calquence (acalabrutinib) with bendamustine and rituximab for adults with previous...[ Price : $8.95]
CDRHs annual report says it granted marketing authorization to 120 novel devices in 2024, which was four less than the previous ye...