Summary
H2 2026 is expected to be a highly active FDA regulatory period, with decisions spanning oncology, nephrology, infectious diseases, neurology, hematology, and rare diseases, reflecting greater therapeutic diversity beyond oncology dominance.
Key innovation trends include first- and best-in-class biologics, RNA-based therapies, long-acting antivirals, precision oncology drugs, advanced imaging diagnostics, and patient-friendly subcutaneous formulations.
Promising candidates that are expected to launch in H2 2026 include Celcuity's gedatolisib, Replimune's vusolimogene oderparepvec (RP1), Merck's subcutaneous KEYTRUDA, Gilead Sciences' bictegravir plus...
