PolyPid signs Azurity partnership for D-PLEX100 commercialization in the U.S. and Canada
PolyPid’s Azurity partnership gives D-PLEX100 a U.S. and Canada launch path after Phase 3 SHIELD II surgical site infection data
Pharma & Biotech
Pharma & Biotech
Immunome moves varegacestat into FDA review for adult desmoid tumors
Immunome has received U.S. Food and Drug Administration acceptance of its New Drug Application for varegacestat, an investigational once-daily oral gamma secretase inhibitor for adults with desmoid tumors. The application is supported by the Phase 3 RINGSIDE trial and carries an April 28, 2027 target action date, placing the targeted oncology company in a defined
Pharma & Biotech
Cogent advances third bezuclastinib FDA submission after APEX pivotal trial results
Cogent’s bezuclastinib NDA for advanced systemic mastocytosis is backed by APEX data showing 65% ORR and deep KIT-driven disease marker reductions.
Pharma & Biotech
Why the FDA extended its adrabetadex review and what it means for Beren Therapeutics
Adrabetadex faces a longer FDA review in infantile-onset NPC. The delay could shape rare-disease drug standards in 2026.