Shots:
Approval numbers were lower, but the impact remained strong the FDA cleared one new drug in January 2026 versus three in January 2025, reflecting continued innovation in areas of high unmet need
Zycubo from Sentynl Therapeutics was approved for pediatric Menkes disease, offering a targeted treatment for this rare, life-threatening genetic copper deficiency disorder
Clinical results were striking, showing…
Shots:
The US FDA has approved Zycubo (copper histidinate) for the treatment of pediatric patients with Menkes disease
Approval was supported by clinical data showing improved OS with early Zycubo treatment vs an untreated external control, reflecting ~80% reduction in the risk of death & a mOS of 177.1 vs 17.6mos.
Zycubo is a bioavailable…
The EMA approved 7 New Chemical Entity (NCE) and 4 Biologic Drugs in Sept 2022, leading to treatments for patients and advances in the healthcare industry
In September 2022, the major highlights drugs were Imcivree approval for bardet-biedl syndrome, Opdualag for unresectable or metastatic melanoma, Ultomiris for generalised myasthenia gravis
PharmaShots has compiled a list…

