Martin Makary

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Biotech

Regenxbio's Hunter gene therapy latest to face FDA delay

The review extension and request for more data bears the fingerprints of recently returned CBER head Vinay Prasad, M.D.
Darren Incorvaia Aug 19, 2025 10:30am
FDA
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FDA taps George Tidmarsh to lead CDER

Jul 21, 2025 10:53am
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Favicon Fierce Pharma

FDA's response letter salvo sheds light on drug refusal process

Jul 11, 2025 10:15am
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Biotech leaders urge FDA to not restrict abortion pill access

Jul 2, 2025 2:14pm
FDA
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FDA's acting CDER head heads for the exit: report

Jun 23, 2025 1:48pm
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FDA debuts priority review voucher with 2-month timeline goal

Jun 17, 2025 11:59am