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Divided US FDA AdComm Backs Molnupiravir Authorization But Wants More Studies

 
• By Brenda Sandburg

In 13-10 vote, panel finds reduction in COVID-19 hospitalizations and deaths outweighs risks. Four members say FDA should reconsider authorization if a more effective and safer therapy comes along. They concur molnupiravir should not be recommended for use in pregnancy but available to those who want it.

Molnupiravir
US FDA advisory committee favors FDA authorization of Merck's molnupiravir • Source: Alamy

A slim majority of US Food and Drug Administration advisory committee members concluded that Merck & Co., Inc.’s molnupiravir showed sufficient efficacy in reducing hospitalizations and deaths in those with mild to moderate COVID-19 to outweigh potential risks. But many expressed reluctance in making this call and recommended that the company conduct additional studies, including in the vaccinated and immunocompromised.

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US FDA’s March Approval Candidates Take Aim At Established Markets

 
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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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‘Pipeline In A Pill’ Or Pipe Dream? US FDA’s April Goal Dates Test Expansion Strategies

 
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Global Pharma Guidance Tracker – February 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.

EU CHMP Opinions And MAA Updates

 
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