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The FDA changes the rules — rare disease patients pay with their lives

The Food and Drug Administration just dealt a crushing setback to patients living with Duchenne muscular dystrophy. Last week, the FDA’s advisory committee voted 9–3 that the evidence was insufficient to establish the effectiveness of Deramiocel, Capricor Therapeutics’ treatment for a heart condition associated with DMD. That decision will stand, and patients will suffer and […]

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Washington ExaminerLean R·1h ago
The FDA changes the rules — rare disease patients pay with their lives
The Food and Drug Administration just dealt a crushing setback to patients living with Duchenne muscular dystrophy. Last week, the FDA’s advisory committee voted 9–3 that the evidence was insufficient to establish the effectiveness of Deramiocel, Capricor Therapeutics’ treatment for a heart condition associated with DMD. That decision will stand, and patients will suffer and […]
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The FDA changes the rules — rare disease patients pay with their lives

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