The FDA has outlined a new review process for drugs and biologics designed to treat ultrarare genetic diseases that would allow a single-arm trial, plus other supportive data, to serve as pivotal ...
Heart disease is the leading cause of death in the U.S. for men and women, according to the federal Centers for Disease Control. The CDC said 919,032 people died in 2023 from cardiovascular diseases ...
The US Food and Drug Administration’s (FDA’s) approval decision about a new treatment for non–muscle invasive bladder cancer (NMIBC) hinges on whether a single-armed trial can be trusted to adequately ...
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