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

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

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

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 ...

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, ...

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

Priority review was based on results from the Phase IIb SunRISe-1 trial, which showed that patients treated with TAR-200 for ...

Johnson & Johnson (NYSE:JNJ) announced on Thursday that the U.S. FDA granted priority review for its new drug application aimed at getting marketing approval for TAR-200, a drug-releasing system for ...

US FDA accepts New Drug Application under Priority Review for sevabertinib (BAY 2927088) in HER2-mutant non-small cell lung cancer. News release. Bayer. May 28, 2025.

References: Eylea HD® (aflibercept) injection 8mg sBLA accepted for FDA Priority Review for both the treatment of macular edema following retinal vein occlusion (RVO) and for monthly dosing in ...

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 sets an August 31, 2025, action date for Capricor’s deramiocel BLA review. Capricor may receive a Priority Review Voucher if approval comes by September 2026. Get daily-updated rankings ...