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

Targeted Oncology connects oncology professionals with updates on immunotherapy, biomarkers, cancer pathways, and targeted precision medicine strategies.

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

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

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 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 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 ...

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

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

The U.S. Food and Drug Administration may reportedly fast-track new drugs from pharmaceutical companies that “equalize” the cost of their medicines between the US and other countries. FDA Commissioner ...

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

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