(RTTNews) - Rhythm Pharmaceuticals (RYTM) announced that the United Kingdoms Medicines & Healthcare products Regulatory Agency or MHRA has expanded the marketing authorization for IMCIVREE or ...
The FDA has shared draft guidance on the design and development of AI-enabled medical devices and marketing submissions for those devices.
SC AG (4SC, FSE Prime Standard: VSC), a biotech company improving the lives of patients suffering with advanced-stage cutaneous T-cell lymphoma (CTCL), today announced that it had submitted its ...
AstraZeneca (NASDAQ:AZN) and Daiichi Sankyo (OTCPK:DSKYF) announced Tuesday they have withdrawn the EU marketing application ...
Only Device Approved to Deliver First Disease-Modifying Treatment for AADC Deficiency in the United States "Today's De Novo approval will give confidence to all our current and future biopharma ...
Norgine today announced that it completed its marketing authorisation application filing to European Medicines Agency (EMA) for eflornithine in high-risk neuroblastoma (HRNB). This follows the ...
AstraZeneca said it and Daiichi Sankyo decided to voluntarily withdraw the marketing authorization application in the European Union for advanced lung-cancer treatment Dato-DXd. This decision followed ...
LONDON, Jan. 7, 2025 /PRNewswire/ -- Norgine today announced that it completed its marketing authorisation application filing ...
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