Guideline-specific management of atrial fibrillation; Focus on ticagrelor; Agents in late-stage development for the treatment of epilepsy and seizure disorders
FDA Assigns Review Date for Gene Therapy for Rare Immune Disorder
FDA has set an action date of March 31, 2024, for marnetegragene autotemcel to treat infants with a serious and often fatal immunodeficiency.
FDA Approves First Biosimilar of Arthritis Med Actemra
Biogen is still evaluating launch timeline for Tofidence, and information on pricing will be available closer to launch.
Health Plans Release 2024 Prescription Changes in Medicare Plans
Aetna, Cigna, Humana, United Healthcare — some of the largest providers of Medicare Advantage plans — have released updates to prescription drug programs.
FDA Issues CRL for Lebrikizumab in Atopic Dermatitis
At issue are findings from the agency’s inspection of a third-party manufacturing company. The FDA indicated there were no concerns about the safety or labeling of lebrikizumab.
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.
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