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Keeping Track: A Quintet Of Novel Approvals

 
• By Michael Cipriano and Bridget Silverman

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

Keeping Track Feature image

Here's your news in brief: It was by far the US Food and Drug Administration's busiest week of the year for novel drug approvals with five such products getting the green light from the agency: Genentech Inc.'s Rozlytrek (entrectinib), Celgene Corp.'s Inrebic (fedratinib), the Global Alliance for TB Drug Development's pretomanid, Harmony Biosciences LLC’s Wakix (pitolisant) and AbbVie Inc.’s Rinvoq (upadacitinib).

The Center for Drug Evaluation and Research's novel drug approval count has now

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Mesoblast’s Ryoncil: US FDA Changed Its Mind On Need For A Randomized Trial

 
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Ryoncil Chronology: Three Review Cycles, Two CRLs, One Dispute Resolution Request

 
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The Pink Sheet’s Drug Review Profile looks at the timeline for the clinical development and US FDA review of Mesoblast’s remestemcel for graft-versus-host disease.

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