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FDA approves treatment for refractory multiple myeloma
Accelerated approval has been granted to Xpovio to treat refractory multiple myeloma by the FDA.
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US Food and Drug Administration (FDA)
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FDA issues three warning letters to API re-packers
Three API re-packers who failed to meet current good manufacturing practice requirements have received warning letters from the FDA.
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First PI3K inhibitor for breast cancer approved by FDA
The US Food and Drug Administration (FDA) has approved Piqray (alpelisib) tablets to treat patients with breast cancer.
article
Concerns around Annex 1
This article expresses the opinions of a pharmaceutical microbiologist on the proposed revisions to the EU Good Manufacturing Practice Annex 1 in terms of current industry practice and future innovation in sterile product manufacturing.
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FDA sends four warning letters for cGMP violations
The US Food and Drug Administration has posted warning letters to four companies who produce homeopathic drug products for significant violations of current good manufacturing practice (cGMP) regulations...
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Darolutamide NDA to treat non-metastatic castration-resistant prostate cancer
A New Drug Application has been made to the US Food and Drug Administration for the drug darolutamide to treat non-metastatic prostate cancer...
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Programs to promote innovations in drug manufacturing
Innovations in drug manufacturing could result in higher quality drugs at less of the cost, and the FDA is willing to help facilitate this development...
