Sprout Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review for its ...

The FDA recently unveiled a new national priority voucher program that would seek to trade faster drug approvals for lower ...

The FDA has begun accepting applications for a priority pathway designed to slas | The FDA has begun accepting applications for a priority pathway designed to slash review times to one to two months, ...

The FDA has accepted the resubmitted BLA for tabelecleucel (tab-cel), intended for the treatment of Epstein-Barr virus ...

Through its recently unveiled Priority Voucher program, the FDA seeks to accelerate the review process for companies that ...

The FDA has accepted for Priority Review the BLA for tividenofusp alfa for the treatment of Hunter syndrome, also known as MPS II.

The FDA has granted Priority Review to TAR-200 for the treatment of patients with BCG-unresponsive high-risk non-muscle invasive bladder cancer with carcinoma in situ, with or without papillary tumors ...

FDA grants priority review to TAR-200, which demonstrated an 82% complete response in high-risk bladder cancer unresponsive ...

FDA Commissioner Marty Makary said during an interview with Bloomberg Television that his agency may expedite reviews of ...

The FDA has accepted for priority review a new supplemental biologics license application for Winrevair to treat adults with advanced pulmonary arterial hypertension, according to a press release from ...

This priority review voucher program (PRV) was created by Congress, initially for rare and neglected diseases, then later expanded to include rare pediatric diseases.

Denali Therapeutics, Inc. DNLI announced that the FDA has accepted for review its biologics license application (BLA) for lead-pipeline candidate tividenofusp alfa. The BLA is seeking accelerated ...