Healio6d
FDA approves expanded label for Iluvien
The FDA approved an expanded label for Iluvien, which is now indicated for the treatment of chronic noninfectious uveitis ...
Fierce Pharma3d
Dr. Reddy’s, Sun Pharma and Zydus issue US recalls, citing failed specs and labeling issues
The companies in question, Dr. Reddy’s Laboratories, Sun Pharma and Zydus Pharmaceuticals, are recalling seizure treatments, ...
Travere Therapeutics Submits sNDA to FDA for Approval of FILSPARI® (sparsentan) for the Treatment of FSGS
NDA submission based on results from Phase 3 DUPLEX and Phase 2 DUET studies of FILSPARI in FSGSIf approved, FILSPARI could become the first and ...
pharmaphorum6d
PDURS explained: The FDA’s new framework for adding software to drug labels
The US FDA has recently proposed a new draft framework that enables pharma manufacturers to add software to a drug label if they can demonstrate that the software adds clinical benefit to the drug.