EMA grants AR-501 with Orphan Drug Designation
Orphan Drug Designation has been given to AR-501 for the treatment of lung infection in patients with cystic fibrosis.
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Orphan Drug Designation has been given to AR-501 for the treatment of lung infection in patients with cystic fibrosis.
Accelerated approval has been granted to Xpovio to treat refractory multiple myeloma by the FDA.
Three API re-packers who failed to meet current good manufacturing practice requirements have received warning letters from the FDA.
The US Food and Drug Administration (FDA) has approved Piqray (alpelisib) tablets to treat patients with breast cancer.
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.
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...
A New Drug Application has been made to the US Food and Drug Administration for the drug darolutamide to treat non-metastatic prostate cancer...
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...