FDA Alerts

The Food and Drug Administration approved azacitidine (Vidaza, Celgene Corp.) for pediatric patients with newly diagnosed juvenile myelomonocytic leukemia (JMML).

The Food and Drug Administration approved axicabtagene ciloleucel (Yescarta, Kite Pharma, Inc.) for adult patients with large B-cell lymphoma (LBCL) that is refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoi...

The HHS Secretary declared that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic.

The Food and Drug Administration authorized a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 vaccines for older people and certain immunocompromised individuals.

The Food and Drug Administration approved ciltacabtagene autoleucel (CARVYKTI, Janssen Biotech, Inc.) for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome i...

FDA has approved Enjaymo (sutimlimab-jome) infusion to decrease the need for red blood cell transfusion due to hemolysis (red blood cell destruction) in adults with cold agglutinin disease (CAD).

The FDA has granted accelerated approval for Oxbryta (voxelotor) tablets to treat sickle cell disease in pediatric patients aged four up to 11 years.

The Food and Drug Administration approved abatacept (Orencia, Bristol-Myers Squibb Company) for the prophylaxis of acute graft versus host disease (aGVHD), in combination with a calcineurin inhibitor (CNI) and methotrexate (MTX), in adults and pediat...

The Food and Drug Administration approved rituximab (Rituxan, Genentech, Inc.) in combination with chemotherapy for pediatric patients (≥6 months to <18 years) with previously untreated, advanced stage, CD20-positive diffuse large B-cell lympho...

The Food and Drug Administration approved daratumumab + hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech, Inc.) and carfilzomib (Kyprolis, Amgen, Inc.) plus dexamethasone for adult patients with relapsed or refractory multiple myeloma who have re...