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FDA rejects AstraZeneca’s Farxiga treatment
AstraZeneca has been issued with a complete response letter for Farxiga by the FDA meaning that it has rejected the treatment.
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The U.S. Food and Drug Administration (FDA)
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Macleods Pharmaceuticals issues recall due to NMBA impurities
Macleods has issued a recall of 32 lots of drug products that contained trace amounts of NMBA impurities.
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Former FDA Commissioner joins Pfizer’s board of directors
Former FDA Commissioner, Scott Gottlieb, who stepped down from the administration in April, has joined Pfizer’s board of directors.
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US Food and Drug Administration sued over Ruzurgi drug approval
Catalyst Pharmaceuticals Inc has sued the FDA to challenge the recent approval of a lower-cost rival drug.
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More countries added to the EU-US mutual recognition agreement
Luxembourg and the Netherlands have been included in the mutual recognition agreement between the EU and the FDA in the US.
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FDA sends warning letter to Canadian OTC manufacturer
FDA sends warning to Petra Hygienic Systems Int LTD after they find violations of current good manufacturing practices (cGMPs).
