First PI3K inhibitor for breast cancer approved by FDA
29 May 2019 | By European Pharmaceutical Review
The US Food and Drug Administration (FDA) has approved Piqray (alpelisib) tablets to treat patients with breast cancer.
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US Food and Drug Administration (FDA)
Concerns around Annex 1
21 May 2019 | By Dr Tony Cundell - Microbiological Consulting LLC
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.
FDA sends four warning letters for cGMP violations
4 April 2019 | By European Pharmaceutical Review
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...
Darolutamide NDA to treat non-metastatic castration-resistant prostate cancer
27 February 2019 | By Iqra Farooq (European Pharmaceutical Review)
A New Drug Application has been made to the US Food and Drug Administration for the drug darolutamide to treat non-metastatic prostate cancer...
Programs to promote innovations in drug manufacturing
13 February 2019 | By European Pharmaceutical Review
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...
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