SPOTLIGHT -
Biologic therapy for continuous control of plaque psoriasis
FDA Approves New Pompe Therapy
The two-component therapy of Pombiliti plus Opfolda to treat adults living with late-onset Pompe disease will have an annual list price of $650,000.
FDA Sets Review Date for Odronextamab to Treat Blood Cancers
Odronextamab is a bispecific antibody to treat relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma. The target action date is March 31, 2024.
FDA Approves Extended-Release Therapy for Major Depression
Exxua is approved to treat adults with major depressive disorder, but its labeling does not contain warnings about sexual function or weight gain.
FDA Grants Priority Review for Sotatercept in Pulmonary Arterial Hypertension
Sotatercept is a first-in-class therapy to treat the rare disease pulmonary arterial hypertension. The FDA has assigned a target action date of March 26, 2024.
FDA Approves Drop for Drug-Induced Dilation of the Pupils
Ryzumi is expected to be available in the first half of 2024. Pricing will be available around the time of launch.
FDA Assigns Review Date for Dupixent in Young Children with Eosinophilic Esophagitis
The FDA has assigned a target action date of Jan. 31, 2024, for Dupixent to treat children 1 to 11 years of age with the inflammatory condition eosinophilic esophagitis.
