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- Sanofi asks FDA to withdraw teplizumab from fast-track review after internal disagreementSanofi has formally requested that the U.S. Food and Drug Administration remove its type 1 diabetes therapy, teplizumab, from the agency's new speedy review program. The request follows a disagree…
- Atara and Pierre Fabre's T-cell therapy gets new chance for FDA approval after twice rejectedAtara 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…