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Latest From Atox Bio

US FDA Novel Approvals Grew To 60 In 2021; CDER Cleared 50 New Agents, Turned Down 18

Approval total is one of FDA’s highest, but the large number of complete response letters obscures the staggering total of almost 80 new molecular entities and novel biologics that the agency acted on over the year.

Approvals US FDA Performance Tracker

10 US Approval Decisions To Look Out For In Q3

This quarter has already seen a complete response letter for Iterum Therapeutics’ antibiotic sulopenem but a raft of other products are expecting approval decisions from the US Food and Drug Administration in the next three months. With the help of analysts at Biomedtracker, Scrip takes a look at 10 of the more interesting ones.

Approvals Companies

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

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

Approvals Complete Response Letters

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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