[ Price : $8.95]
FDA issues an amended Warning Letter to Sanofis Genzyme unit in Framingham, MA, about CGMP deviations in its manufacturing of acti...[ Price : $8.95]
FDA approves a Johnson & Johnson supplemental NDA for Spravato (esketamine) nasal spray for monotherapy use in treating major depr...[ Price : $8.95]
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]
Atara Biotherapeutics says it has reached an agreement with FDA on the steps needed to lift agency clinical holds on its Ebvallo a...