FDA grants Priority Review to Takeda’s zasocitinib after Phase 3 psoriasis studies, including head-to-head superiority versus deucravacitinib.
CSL Seqirus’ 7,699-person Phase 3 study supports its enhanced flu-vaccine strategy, though one A/H3N2 comparison missed non-inferiority.
FDA clears Full-Life’s actinium-225 FL-261 for Phase 1 testing in c-MET-positive lung cancer as the radiopharmaceutical company expands its pipeline.
FDA clears Alebund’s AP308 for human testing in IgA nephropathy, taking a novel IgA-cleaving strategy beyond promising preclinical data.
FDA grants orphan status to Lundbeck’s asedebart for endogenous Cushing’s syndrome as Phase 2 testing examines direct ACTH neutralization.
Hikma’s epinephrine nasal spray enters regulatory review in the U.S., Europe and UK as competition grows in needle-free anaphylaxis treatment.
FDA clears a CU Anschutz trial of B7-H3 CAR T cells engineered to follow IL-8 signals into colorectal and pediatric solid tumors.
IDEAYA and Servier begin a 450-patient Phase 3 trial testing whether darovasertib plus crizotinib can prevent uveal melanoma recurrence.
Tyra Biosciences’ dabogratinib showed encouraging single-lesion responses in SURF302, but mixed broader data sent shares sharply lower.
BioMarin’s VOXZOGO met its Phase 3 hypochondroplasia endpoint with a 2.33 cm/year growth velocity benefit as an FDA filing moves forward.