Safety & Recalls

November 27th 2023

The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of May 25, 2024, for prademagene zamikeracel to treat patients with recessive dystrophic epidermolysis bullosa.

November 27th 2023

This is the second recall of Sandimmune related to the formulation of crystals in some bottles.

November 20th 2023

Contamination with Penicillium brevicompactum could lead to invasive fungal infections of the blood or pneumonia that can be life-threatening in immunocompromised patients.

October 27th 2023

Based on reports from post-marketing experience, Spravato’s warnings and precautions section now includes the risk of respiratory depression.