The FDA has adjusted the label of Johnson & Johnson and Legend Biotech’s Carvykti, warning patients and doctors that use of the multiple myeloma treatment could increase the risk of an intestinal ...

Lizzy Lawrence spoke with more than 20 current and former FDA staff, interviewed legal experts, and reviewed agency documents to report this story. Lizzy Lawrence leads STAT’s coverage of the Food and ...

The FDA approved updated labeling for Carvykti (ciltacabtagene autoleucel, Janssen Biotech) to include a new boxed warning for immune effector cell-associated enterocolitis (IEC-EC). Carvykti is a ...

Effective Oct. 31 the FDA will require import certifications for all shrimp and spices within certain parts of Indonesia because of the risk of radioactivity. The move comes after levels of the ...

The Food and Drug Administration is recalling 16 brands of cinnamon that contain elevated lead levels, which over time can cause neurological problems including learning disabilities in young children ...

The Food and Drug Administration said in a pair of new health alerts that it has identified additional cinnamon products sold in the U.S. that were found to contain elevated levels of lead. In a Oct.

Peter Marks, M.D., Ph.D., the former head of the FDA’s Center for Biologics Evaluation and Research (CBER), has joined Eli Lilly as senior vice president of molecule discovery and head of infectious ...

Big pharmaceutical companies are boosting their production capacity of branded medications with billions of dollars in new U.S. manufacturing plant construction, but generic drug production still ...

The U.S. Food and Drug Administration is reviewing whether to change the warning label on hormone replacement therapy drugs used to treat menopause symptoms, a move many experts say is long overdue.

Roche, which currently has investigational Alzheimer’s disease drug trontinemab in phase 3 trials, has secured FDA clearance of its blood-based biomarker test for the condition. The minimally invasive ...

The Food and Drug Administration continues to warn consumers about 16 cinnamon products that contain lead, a warning initially announced in 2024. Ground cinnamon products from a dozen brands have been ...

The FDA has approved an expanded indication for risperidone (Uzedy, Teva) extended-release injectable suspension, allowing it to be used for the maintenance treatment of bipolar I disorder in adults, ...