It seems as if the US FDA's calling of an advisory committee to vote on the risk/benefit profile of GW Pharmaceuticals PLC's childhood epilepsy drug Epidiolex (cannabidiol) is largely designed to cover the agency's bases, in that there is no agency-approved drug containing the marijuana derivative.
Epidiolex Advisory Committee Appears To Be Covering US FDA's Bases, But Liver Injury Concerns Persist
Panel for first-ever marijuana derivative will discuss safety issues, including link to transaminase elevations, but low potential for abuse and strong efficacy suggest a smooth route to approval.
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March features nearly 20 user fee goal dates, including a crowd of novel candidates for crowded areas like hemophilia, heart disease and urinary tract infections, as well as the potentially first therapies for a rare eye disease and hyperphagia of Prader-Willi syndrome.
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The US FDA approval of new meningococcal and chikungunya vaccines arrived in time for the 26-28 February meeting of the CDC’s Advisory Committee On Immunization Practices, if political developments allow.
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This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
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March features nearly 20 user fee goal dates, including a crowd of novel candidates for crowded areas like hemophilia, heart disease and urinary tract infections, as well as the potentially first therapies for a rare eye disease and hyperphagia of Prader-Willi syndrome.
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The European Medicines Agency is set to issue opinions this week on whether pan-EU marketing approval should be granted to a number of new products.