Tag:
FDA priority review
Latest Headlines
Latest Headlines
Pfizer cancer drug takes big step toward fateful FDA decision
After wrapping up an orphan drug designation and fast track status late last year, Pfizer can now add a priority review stamp to its list of accomplishments for crizotinib, its late-stage lung cancer
Benlysta, BMS melanoma drug win accelerated FDA review
Two of the most closely watched therapies now awaiting a final decision at the FDA won an accelerated regulatory review. Human Genome Sciences will have four months shaved off the usual review
Cadence's Acetavance gets priority review
The FDA has granted Cadence Pharmaceuticals priority review for its Acetavance NDA. Acetavance (intravenous acetaminophen) is being reviewed for the treatment of acute pain and fever in adults and
Auxilium's xiaflex BLA granted priority review
PA-based Auxilium Pharmaceuticals announced today that the FDA has accepted its biologics license application for Xiaflex and granted the submission priority review. Xiaflex is a first-in-class
