NovoLog insulin aspart approved for pediatric use

The designations follow the FDA acceptance of IND application for ABO-101 to treat PH1, with a phase 1/2 study planned in the first half of 2025.

"I’m all for reducing opioids, especially in neonates, for whom we are unsure of long-term adverse effects," stated Jon Matthew Farber, MD.

Application submission is based on positive phase 3 data that demonstrated improvement in patients with type 2 and 3 SMA receiving current standard of care.

As a biosimilar to Actemra, tocilizumab-anoh in both IV and SC formulation is approved to treat rheumatoid arthritis, pJIA, sJIA, COVID-19, and giant cell arteritis.