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
Find out how Compass Pathways’ COMP360 Phase 3 data could shape regulated psilocybin treatment for depression.
Johnson & Johnson has received U.S. Food and Drug Administration approval for the Dual Energy Thermocool Smarttouch SF Platform, an integrated cardiac ablation system that allows electrophysiologists to deliver both radiofrequency and pulsed field energy through a single catheter. The approval places the Johnson & Johnson MedTech electrophysiology business into a more direct U.S. rollout
Find out how UroGen Pharma’s UGN-501 could test oncolytic virus therapy for recurrent non-muscle invasive bladder cancer.
Arcutis Biotherapeutics has secured U.S. Food and Drug Administration acceptance of its supplemental New Drug Application for Zoryve roflumilast cream 0.05 percent to expand treatment of mild to moderate atopic dermatitis to infants aged 3 to 24 months. The filing moves the steroid-free topical therapy into a regulatory review with a target action date of
Find out how Gain Therapeutics’ GT-02287 could test GCase restoration as a disease-modifying strategy for Parkinson’s disease.
Find out how Vera Therapeutics’ TRUTAKNA approval could reshape IgA nephropathy treatment while key kidney data remain ahead.
Find out how Shape Memory Medical’s AAA-SHAPE trial could reshape aneurysm sac management after EVAR.
Find out how Keenova’s XIAFLEX Phase 3 success could create the first approved drug for plantar fibromatosis.
Find out how Johnson & Johnson’s dual-energy ablation system could reshape cardiac arrhythmia procedures.