U.S. FDA

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FDA snubs Sobi’s gout drug over manufacturing issues

The FDA cited deficiencies at a contract manufacturing facility and is requiring additional data related to manufacturing control strategy.
Angus Liu Jun 29, 2026 11:04am
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Obesity meds, China drive $2T in projected 2032 drug sales: report

Jun 23, 2026 9:00am
Regenxbio

In another reversal, FDA to reconsider Regenxbio gene therapy

Jun 22, 2026 10:26am
Moderna

FDA appears less prickly toward Moderna mRNA flu shot

Jun 16, 2026 2:46pm
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Biopharma rallies behind Pazdur to lead FDA. But is he willing?

May 14, 2026 11:05am
Martin Makary FDA Senate HELP confirmation
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FDA's embattled Marty Makary steps down as commissioner

May 12, 2026 2:30pm