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EMA’s Rasi: Approval Decision For Remdesivir May Come ‘Very Soon’

 
• By Neena Brizmohun

Speaking at a high-level European Parliament committee meeting today about COVID-19, the European Medicines Agency’s executive director indicated that Gilead would be submitting a conditional marketing authorization application for remdesivir in the EU.

Drug remdesivir for covid 19 coronavirus treatment
The EMA is conducting a rolling review of remdesivir for treating COVID-19 • Source: Shutterstock

A decision by the European Medicines Agency on whether Gilead Sciences’ remdesivir should be authorized in the EU for treating patients with COVID-19 could “come very soon,” according to the agency’s executive director, Guido Rasi.

It might be that a decision on "conditional marketing authorization can be issued in the coming days, subject to the...

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AI And Inertia: The Disruptors Keeping EU Regulators Awake At Night

 
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Data is “the new oil,” but its use will challenge regulators, while inertia is the biggest disrupter of all for European regulators, according to European Medicines Agency chiefs past and present.

More from Geography

EMA’s PRIME Scheme Explored: Growing Designations - But Are Accelerated Assessments Slipping?

 
• By Neena Brizmohun

While the first six months of the year saw eight new drugs targeting a range of diseases enter the European Medicines Agency’s priority medicines scheme, and three PRIME-designated treatments go on to win EU marketing approval, use of the accelerated assessment mechanism appears to be limited.

Global Pharma Guidance Tracker - June 2025

 
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Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

US FDA’s CRL Release More Incremental Than ‘Radical’ Transparency

 
• By Bridget Silverman

The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.