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Rhone-Poulenc Rorer Pharmaceuticals Inc.

Division of Sanofi

Latest From Rhone-Poulenc Rorer Pharmaceuticals Inc.

Biogen Aducanumab BLA Plan Is In Line With US FDA Neurology Division Precedent

Biogen and Eisai's surprise decision to advance Alzheimer’s antibody despite mixed clinical results could follow a similar path as pioneering neurodegenerative therapies Xenazine and Rilutek, or more recent Parkinson’s drug Nourianz – or could end with suspended development, like Kyndrisa.
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Keeping Track: US FDA Closes Out First Half Of 2019 With CRL For Edsivo, But A Burst Of Supplemental Approvals

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

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US FDA Approval Actions To Watch Out For In June

User fee goal date calendar for June includes AMAG’s female sexual dysfunction drug Vyleesi, new indications for Sanofi/Regeneron’s Dupixent in rhinosinusitis and Merck’s Zerbaxa in nosocomial pneumonia.

Drug Review Drug Approval Standards

Keeping Track: FDA Starts November With A Bang

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