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Do FDA Submission, Approval Declines Outside Cancer Signal Future Treatment Gaps?

 
• By Derrick Gingery

Outlining a "fairly substantial decline in the number of non-oncology NMEs approved compared to last year" plus downward trend in applications, US FDA's Jenkins underscores continued "tremendous needs" for primary care products.

FDA entrance sign 2016

While oncology drug development continues to be fairly lively, a drop in FDA applications and approvals in other therapeutic areas may raise concerns about the longer-term outlook for treatment options.

Reviewing data on applications received and approved by the Center for Drug Evaluation and Research since 2013, Office of New...

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US FDA’s June Approval Forecast: Infection Prevention, Cancer And HAE

 
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New EU Approvals

 
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Autolus’s Aucatzyl And GSK’s Blenrep Among 10 New Drugs To Get EMA Nod

 
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EU Authorization Before US? Biologics Manufacturing Is Likely To Blame

 
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EMA Touts Faster Global Post-Approval Changes Via Regulatory Reliance

 
• By Eliza Slawther

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New EU Approvals

 
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US FDA Meeting Drought Ends … With A Vengeance

 
• By Michael McCaughan

The first 100 days of the Trump Administration were notable for an extraordinary decline in the number of public meetings hosted by the US Food and Drug Administration. But the schedule changed quickly.