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BioPharmaceutical Regulation

Keeping Track: FDA On A Complete Response Spree?

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Executive Summary

The latest drug development news and highlights from our FDA Performance Tracker.

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Newron's Parkinson's Disease Drug Xadago Priced At $600-700/Month

First new chemical entity for Parkinson's to clear FDA in 10 years, Xadago has a narrower indication than Teva's Azilect and similar pricing.

Newron's Parkinson's Drug Xadago Has Narrower Indication Than Teva's Azilect

After overcoming regulatory hurdles, Newron may have tough time competing in US against market stalwart Azilect; eight Parkinson's drugs are in Phase III trials.

Keeping Track: Opdivo Dosing Simplified; Yosprala, Cuvitru Approved; Telotristat Review Lengthened

The latest drug development news and highlights from our FDA Performance Tracker.

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