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Keeping Track: A Massive Week Of Agency Approvals

 
• By Michael Cipriano

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

Here's your news in brief: Approvals galore was the theme of the week, with the US FDA approving at least nine product applications. The biggest regulatory development was clearance of the first indication based on a basket trial, Genentech Inc.'s supplemental approval of its kinase inhibitor Zelboraf (vemurafenib) for the treatment of patients with Erdheim-Chester Disease (ECD) with a BRAF V600 mutation.

Most notably in original approvals, the agency finally gave its blessing to Dynavax Technologies Corp.'s hepatitis B vaccine Heplisav-B...

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