Disc Medicine has received a complete response letter (CRL) from the US Food and Drug Administration (FDA) concerning its new drug application (NDA) for bitopertin for erythropoietic protoporphyria (EPP).
The clinical study, dubbed COLCORONA, will assess whether colchicine will serve as an effective treatment to prevent the phenomenon of major inflammatory storm present in adults suffering from
In addition, the companies have completed a cross-license of their respective intellectual property for Alnylam’s lumasiran and Dicerna’s nedosiran investigational programs for the treatment of primary hyperoxaluria (PH).
Under the terms of the agreement, Second Genome will utilize its proprietary Microbiome Analytics Platform™ to identify novel biomarkers associated with clinical response to Gilead’s investigational medicines. This
BioArdis will retain all rights to the licensed product in the rest of the world. BIO-1262 is being evaluated as a potential new treatment for hepatocellular carcinoma (HCC)
The FDA created the Fast Track process to facilitate the development and expedite the review of drugs to treat serious or life-threatening diseases or conditions, which have the
Myelodysplastic syndromes are a group of closely related blood cancers characterised by ineffective production of healthy red blood cells, white blood cells and platelets, which may cause anaemia
This expansion includes up to three additional targets focused on host factors for SARS-CoV-2, including ACE2 and TMPRSS2, both of which are considered critical for viral entry, with
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