Dr. Vinay Prasad is back at the FDA's Center for Biologics Evaluation and Research, raising eyebrows after being ousted amid political turmoil and criticism. His return ignites debates about drug approvals and public health leadership under the Trump administration.
Sarepta Therapeutics' gene therapy for Duchenne muscular dystrophy is on hold due to safety issues. An FDA official warns the path to market approval is fraught with challenges, especially after patient deaths linked to liver injuries.
