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Approvals Complete Response Letters US FDA Performance Tracker

Keeping Track: J&J Amivantamab, Infectious Disease Agents From Iterum, VBI And Atox Submitted; Another Furoscix CRL

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Executive Summary

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

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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.

Guardant Will Collaborate With Janssen On Lung Cancer Companion Diagnostic

The companies expect the Guardant360 CDx liquid-biopsy test to identify patients who will benefit from amivantamab, Janssen’s investigational drug for non-small cell lung cancer.

Atox ‘Remains On Track’ Despite ACCUTE Setback

After talking with the FDA, Atox will file an NDA for its necrotizing soft tissue infections therapy despite missing primary endpoints in a pivotal trial, the biotech’s CEO tells Scrip.

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Approvals Complete Response Letters US FDA Performance Tracker
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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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