Browsing Tag
priority review
3 posts
Pfizer-backed Priovant wins FDA priority review for brepocitinib in dermatomyositis
FDA grants priority review to Priovant's brepocitinib NDA for dermatomyositis with a Q3 2026 PDUFA date. Read what this means for Roivant, Pfizer, and the autoimmune market.
How Hansa Biopharma’s imlifidase could redefine access for hardest-to-match transplant candidates
Hansa Biopharma seeks FDA approval for imlifidase to expand transplant eligibility in high-risk ESRD patients. See what this filing means for U.S. access.
Breakthrough in kidney cancer imaging: FDA fast-tracks Telix Pharmaceuticals’ TLX250-CDx
The United States Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for Telix Pharmaceuticals…