The U.S. Food and Drug Administration started taking applications for its PreCheck pilot, a new effort to accelerate the ...

The FDA has granted fast track designation to LBL-034 for patients with relapsed or refractory multiple myeloma. The U.S.

The Food and Drug Administration (FDA) has granted Fast Track designation to QTX-2101, an oral formulation of arsenic trioxide, for the treatment of acute promyelocytic leukemia (APL), an aggressive ...

The FDA granted fast track designation (FTD) to IBI3003, a first-in-class trispecific antibody, for the treatment of patients ...

QTX-2101 is an investigational, oral arsenic trioxide therapy that has not yet been approved by any regulatory authority. Its ...

The FDA has granted fast track designation (FTD) to LBL-034, an investigational GPRC5D/CD3 bispecific T-cell engager (BiTE), for patients with relapsed/refractory multiple myeloma (R/R MM).

FDA delayed fast-track reviews for multiple drugs after safety and efficacy concerns, including adverse events and a reported patient death.

Drug Farm, a clinical-stage biopharmaceutical company advancing two novel small molecule drugs for ROSAH syndrome and ...

Novartis received breakthrough therapy designation from the FDA for ianalumab, a monoclonal antibody aimed at treating Sjögren’s disease. Ianalumab works by depleting B cells and blocking BAFF-R ...

The FDA's Fast Track designation helps to accelerate the development and review of products for serious and life-threatening conditions.

A plan to slash drug review times at the Food and Drug Administration is sparking deep concerns among agency staffers and outside experts, with some saying the poorly defined effort is taking key ...