FDA

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Biotech

FDA rejects Capricor’s DMD cell therapy, asks for more data

The rejection raises questions about whether the new-look FDA leadership may be rowing back from some of the flexibility shown by the old regime.

Nick Paul Taylor Jul 11, 2025 9:18am

Image of a neon sign with the word no lit up next to an unlit yes

FDA shares more than 200 CRLs for now-approved drugs

Jul 10, 2025 10:54am

Mendaera Focalist robot

Mendaera scores FDA clearance for handheld needle robot system

Jul 9, 2025 10:30am

Aktiia Hilo bracelet

FDA clears over-the-counter, cuffless blood pressure wearable

Jul 8, 2025 1:45pm

Rocket with heart on blue background

Boston Scientific expands Farapulse afib reach with new approval

Jul 7, 2025 11:58am

A nurse holding the hands of an elderly patient

FDA clears Fasikl AI stimulation wristwatch for essential tremor

Jul 3, 2025 9:15am