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The decision marks another regulatory U-turn following the exits of Marty Makary and Vinay Prasad, suggesting to some analysts that current FDA leadership may be more flexible in certain cases.

The potentially $4 billion collaboration is the latest example of drugmakers working to broaden the use of T cell engagers, which, so far, have had limited success outside of certain blood cancers.

Vedana Therapeutics emerged from stealth Wednesday with $46 million to support its mission of developing “anti-PACAP” therapies, an increasingly popular strategy for migraine prevention.