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Panel Favors Qnexa Approval, Given Strong Efficacy, Certainty Of Post-Approval CV Study

 
• By Cathy Dombrowski

Office of New Drugs Director John Jenkins reassured panel members of the agency’s ability to assess civil penalties or cite a drug for misbranding if sponsors fail to meet post-market study obligations.

Strong efficacy data and reassurance that FDA has the authority to ensure that a cardiovascular outcomes trial is conducted post-market helped the agency’s Endocrinologic and Metabolic Drugs Advisory Committee vote 20-2 in favor of approving of Vivus Inc.’s weight-loss drug Qnexa.

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AMR-Targeting Drug Secures EMA PRIME Designation

 
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US FDA’s Review Performance Held Steady Despite Stormy First Quarter

 
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Organizational turmoil has not yet affected reviews of novel agent applications, with Q1 2025 approvals coming in low, but the first quarter share of the entire year is variable.

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

 
• By Bridget Silverman

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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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