Atara and Pierre Fabre's T-cell therapy gets new chance for FDA approval after twice rejected
read at Endpoints ↗RegulatoryPositive
Atara Biotherapeutics and Pierre Fabre Pharmaceuticals have received notice from the U.S. FDA that it will reconsider a previously rejected T-cell therapy.
The therapy, which had been turned down twice, may now be evaluated using data from a Phase 3 trial as the primary basis for approval.
If the FDA moves forward, the decision could revive the development program and potentially bring a new cell-based treatment to market.
source
This writeup was produced by pharmadog from original reporting by Endpoints.
Original headline: “Atara, Pierre Fabre's cell therapy to get another shot at FDA approval”
read at Endpoints ↗89 words · retrieved May 8
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