FDA publishes 48 new and revised product-specific guidances in its latest batch.
Federal Register notice: FDA withdraws the approval of seven ANDAs from multiple applicants after they notified the agency that the drugs are no longe...
North American Diagnostics recalls its Oral Rapid SARS-CoV-2 Rapid Antigen Test Kits because they were distributed without FDA authorization, clearanc...
FDA issues a clinical hold on Beam Therapeutics BEAM-201 and its use in treating relapsed/refractory T-cell acute lymphoblastic leukemia/T cell lympho...
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.
