Vaccine agents in late-stage development.
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.
Analysis: Farxiga is a High-Value Medication for Patients with Heart Failure
The recent study also found that Jardiance for patients with heart failure with preserved ejection fraction could be cost-effective if discounted by 29%.
Cross-Contamination Leads to Recall of Two Lots of Brexafemme
Contamination of Brexafemme with a non-antibacterial beta-lactam drug could lead to reactions such as swelling, rash, urticaria and anaphylaxis.
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.
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