FDA

June 12th 2025

Ibtrozi had a 90% response rate in treatment naïve adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer, according to the results of a news release.

June 12th 2025

Enflonsia is the first FDA-approved respiratory syncytial virus (RSV) preventative for infants, regardless of weight, according to the news release.

May 27th 2025

Sibeprenlimab would be offered in a prefilled syringe for subcutaneous injection. The PDUFA target action date is Nov. 28, 2025.

May 23rd 2025

Nucula’s new indication is as an add-on therapy for patients with COPD who also have an elevated blood eosinophil count.