Acelyrin says it will have an independent auditor evaluate contractor research organization issues in trials for its izokibep.
FDA warns Tesuque, NM-based Dr. Bernes Whole Health Products that it is marketing adulterated unapproved eye drops.
FDA opens an investigation into an identified risk of T-cell malignancy following BCMA-directed or CD19-directed autologous chimeric antigen receptor ...
FDA issues a warning on Philips DreamStation 2 continuous positive airway pressure (CPAP) machines and their potential to overheat.
President Biden says his administration will invoke the Defense Production Act to manufacture essential medicines in the U.S. to mitigate drug shortag...
FDA and the Duke-Margolis Center for Health Policy announce a hybrid (online/in-person) public meeting 1/31 on Building Quality into the Design and Co...
Researchers say a hybrid pilot mock drug GMP inspection found that on-site investigators were able to interact with remote participants from national ...
FDA withdraws its membership in the 32-member medical device Global Harmonization Working Party after failing to persuade the organization to align wi...
