Tag Archive for: label expansion

The FDA on Thursday greenlit the label expansion of AstraZeneca’s subcutaneous IL-5 receptor blocker Fasenra (benralizumab), which can now be used as an add-on maintenance treatment for severe eosinophilic asthma in children six to 11 years of age.

If its label expansion is approved, earlier Pluvicto treatment may help patients avoid the toxic side effects of chemotherapy — and may open a larger market for the targeted treatment.

New late-stage trial results for GSK’s Jemperli show improved overall and progression-free survival in a broader range of endometrial cancer patients, which could lead to a potential label expansion.

The agency extended the label for Takeda’s immune globulin infusion as a maintenance therapy for adults with chronic inflammatory demyelinating polyneuropathy.

The biopharma company reported sales of $2.24 billion in the second quarter for the cystic fibrosis treatment, beating analysts’ estimate, after it won FDA approval in children ages two to five in April.