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US FDA Ends 2019 With Second-Highest Approval Count After Second-Half Rebound

 
• By Michael Cipriano

CDER's 48 novel agents, including 35 in the second half of the year, marks the second-highest novel approval count in the contemporary era.

Pink Sheet Perspectives 2019 to 2020
CDER Approved 48 novel agents in 2019, the second highest total of the contemporary FDA.

Sponsors had an exceptional second half of 2019 in obtaining novel drug and therapeutic biologic approvals from the US Food and Drug Administration after struggling during the first six months. And the strong finish resulted in the second-highest novel approval count in a contemporary calendar year.

The FDA's Center for Drug Evaluation and Research (CDER) cleared 35 new molecular entities (NMEs) and novel biologic entities (NBEs)...

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Europe Eyes First Therapies For PSC And cALD In Latest EMA Drug Filings

 
• By Neena Brizmohun

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EU Biosimilar Filings, Opinions And Approvals

 
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Japan Gives Global-First Recommendations To Taisho’s Vornorexant, Santen’s Sepetaprost

 
• By Lisa Takagi

Japan gives world-first approval recommendations to two domestically originated drugs, for insomnia and glaucoma/ocular hypertension.

New EU Filings

 
• By Neena Brizmohun

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EU CHMP Opinions And MAA Updates

 
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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.

Japan Gives Global-First Recommendations To Taisho’s Vornorexant, Santen’s Sepetaprost

 
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