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 sends Aldeyra Therapeutics a complete response letter on its NDA for reproxalap, an investigational drug candidate for treating dry eye disease.
Novartis recalls two lots of its Sandimmune oral solution (cyclosporine) 100 mg/mL due to crystal formation observed in some bottles.
Federal Register notice: FDA extends the comment period on a 10/24 notice on the revised draft guidance entitled Communications From Firms to Health C...
