Federal Register notice: FDA seeks comments on an information collection entitled Reporting Associated With Designated New Animal Drugs for Minor Use ...
FDA accepts for review an ImmunityBio BLA for its antibody cytokine fusion protein as a treatment for certain patients with Bacillus Calmette-Gurin-un...
FDA removes a clinical hold on Celyad Oncologys CYAD-101-002 (KEYNOTE-B79) Phase 1b trial after the company modified the eligibility criteria for the ...
FDA approves Janssens Stelara (ustekinumab) for treating pediatric patients six years of age and older with active psoriatic arthritis.
AstraZeneca says discontinued a monalizumab study after a planned futility interim analysis of the INTERLINK-1 Phase 3 study did not meet a pre-define...
FDA posts a final guidance entitled Changes to Disposable Manufacturing Materials: Questions and Answers.
Law firm Sidley draws attention to a recent southern Florida federal court dismissal of a whistleblower lawsuit that declined to embrace the arguments...
FDA grants Omeros an orphan drug designation for OMS906 and its use in treating paroxysmal nocturnal hemoglobinuria (PNH).
