FDA approvals - January 2026
Copper replacement formalizes care for a fatal pediatric metabolic disorder.
Greenlit
FDA approvals - December 2025
The winter batch of FDA approvals featured therapies that compress intervention into fewer doses, fewer visits, and fewer points of failure.
FDA Approvals - November 2025
Mitochondrial disease and mutant leukemias signal where specialty pharma is placing its biggest bets.
FDA approvals - September 2025
September’s FDA approvals signaled shifting rules in biopharma - faster launches, smarter formulations, and bold plays from rising innovators and the familiar giants.