The US Food and Drug Administration (FDA) has approved Spravato (esketamine), a new nasal spray medication for treatment-resistant depression.
The drug is a bispecific antibody molecule being evaluated in patients with relapsed or refractory acute myeloid leukemia, along with other CD123-expressing haematologic malignancies.
The decision came down to 14 yes votes, two no votes and one abstain, basing their support on the safety and efficacy data from five Phase III studies in patients with treatment-resistant depression: three short-term studies; one maintenance of effect study; and one long-term safety study.
The U.S. Food and Drug Administration today approved Cablivi (caplacizumab-yhdp) injection, the first therapy specifically indicated, in combination with plasma exchange and immunosuppressive therapy, for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP), a rare and life-threatening disorder that causes blood clotting.
The U.S. Food and Drug Administration approved the first generic of Advair Diskus (fluticasone propionate and salmeterol inhalation powder) for the twice-daily treatment of asthma in patients aged four years and older and maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD).