FDA Safety Alert: Pepaxto

The Food and Drug Administration (FDA) issued a safety alert for Pepaxto (melphalan flufenamide; Oncopeptides AB) based on results from the OCEAN trial, which demonstrated an increased risk of death.In February 2021, the FDA approved Pepaxto under Accelerated...

First FDA Approval Based on Real World Evidence

On July 16, the Food and Drug Administration (FDA) approved a new indication for Prograf (tacrolimus; Astellas Pharma US Inc.) based on observational study data providing real-world evidence (RWE) of effectiveness. It is the first drug approval based on RWE. The newly...

FDA Safety Alert: NuVasive MAGEC Devices

The Food and Drug Administration (FDA) issued a safety communication regarding potential mechanical failures and concerns about biocompatibility associated with components of the following NuVasive Specialized Orthopedics MAGEC devices:MAGEC Spinal Bracing and...