FDA

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FDA shares more than 200 CRLs for now-approved drugs

All of the CRLs shared today are for drugs that have since gained approval from the agency, an HHS spokesperson told Fierce.
Gabrielle Masson Jul 10, 2025 10:54am
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Granules recalls blood pressure med for failing to meet specs

Jul 9, 2025 8:46am
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Biotech leaders urge FDA to not restrict abortion pill access

Jul 2, 2025 2:14pm
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Manufacturing issues stunt Unicycive's kidney disease prospect

Jun 30, 2025 11:15am
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Regulatory tracker: Sobi's Gamifant gains new FDA approval

Jun 30, 2025 10:50am
recall

Sandoz recalls one lot of cefazolin due to mispackaging

Jun 30, 2025 9:01am