SAN DIEGO -- Omalizumab (Xolair) injections outperformed oral immunotherapy (OIT) in increasing tolerance among children with ...

Upon beginning Stage 2, all participants received injections of omalizumab for eight weeks. Then the participants were randomly divided in half and placed into one of two groups. Group A received ...

Patients were then randomized to receive either multi-allergen OIT or placebo OIT while continuing Xolair for another 8 weeks. After that, the OIT group switched to placebo injections for an ...

JERSEY CITY, N.J., March 10, 2025 /PRNewswire/ -- Celltrion today announced the U.S. Food and Drug Administration (FDA) approved OMLYCLO ® (omalizumab-igec) as the first and only biosimilar designated ...

Asthma doctors say the move will put their patients at risk of life-threatening reactions when they take the drugs at home.

Study participants that received omalizumab-igec 150mg or reference ... a 150mg/mL single-dose prefilled syringe for subcutaneous injection. The product should be initially administered in a ...

The study design included a carefully structured comparison between the two treatment approaches: All participants initially received omalizumab injections for eight weeks. Participants were then ...

The approval covered two doses matching those of omalizumab -- a 75 mg/0.5 mL injection and a 150 mg/mL injection -- both to be administered in single-dose prefilled syringes for subcutaneous use.

JERSEY CITY, N.J., March 9, 2025 /PRNewswire/ -- Celltrion today announced the U.S. Food and Drug Administration (FDA) approved OMLYCLO® (omalizumab-igec) as the first and only biosimilar ...