Bacillus cereus contamination in Atovaquone Oral Suspension, which treats AIDS-related pneumonia, was found during stability testing at a third-party lab.
One lot of treprostinil injection is being recalled. Tresprostinil is a prostacyclin vasodilator used to treat patients with pulmonary arterial hypertension.
The FDA orders new warnings for CAR-T cell therapies due to reports of T-cell malignancies, including fatal cases, applying to BCMA- and CD19-directed genetically modified autologous T-cell immunotherapies.