Keeping Track: J&J Amivantamab, Infectious Disease Agents From Iterum, VBI And Atox Submitted; Another Furoscix CRL
Executive Summary
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
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Five New EU Filings Leave Starting Blocks at EMA
There is one orphan drug among the five new marketing authorization applications that the European Medicines Agency has under review. All five drugs will be reviewed under standard review timelines.
Genmab Commercial Expansion Opens The Door To New Types Of Deals
The company's CEO talked to Scrip about the expected US launch of tisotumab vedotin likely later in 2021 and the company's partnering strategy going forward.
Plenty Of Action On EU Accelerated Assessment Front
A number of companies have sought to convince the European Medicine Agency that their drug merits a fast-track regulatory review.