The FDA accepted a resubmitted new drug application for reproxalap, a first-in-class investigational topical therapy for dry ...

On February 12, the FDA issued a final rule regarding the use of Drug Master Files (“DMF”) in Biologics License Applications. DMFs are submissions to the FDA “used to provide confidential ...

Key Takeaways Darzalex Faspro's FDA application targets high-risk smoldering multiple myeloma, a precursor to active multiple myeloma with no current approved treatments. The phase 3 AQUILA study ...