FDA Approval
FDA Approval
04/30/2026
Anthony Calabro, MA
The FDA has approved a supplemental indication for lumateperone to reduce relapse risk in adults with schizophrenia based on phase 3 randomized withdrawal data.
04/30/2026
FDA Approval
FDA Approval
04/15/2026
Anthony Calabro, MA
The FDA has granted full approval for the use of brexucabtagene autoleucel in adults with relapsed or refractory mantle cell lymphoma, based on confirmatory ZUMA-2 data.
04/15/2026
FDA Approval
FDA Approval
04/02/2026
Anthony Calabro, MA
The FDA approved oral GLP-1 orforglipron (Foundayo) for weight management without food or water restrictions.
04/02/2026
FDA Approval
FDA Approval
03/19/2026
Anthony Calabro, MA
The FDA has approved icotrokinra, an oral interleukin-23 receptor antagonist, for patients aged 12 years and older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or...
03/19/2026
FDA Alert
FDA Alert
08/19/2024
Anthony Calabro, MA
The nasal spray is the first FDA-approved epinephrine product for the treatment of anaphylaxis not to be administered by injection.
08/19/2024
FDA ALERT
FDA ALERT
04/12/2024

Jessica Bard

Jessica Bard
The FDA has approved sotatercept-csrk, the first activin signaling inhibitor therapy, for the management of patients with pulmonary arterial hypertension (PAH). Based on the Phase 3 STELLAR trial,...
04/12/2024
FDA Alert
FDA Alert
10/04/2023
Jessica Ganga
Following two randomized studies, the FDA has approved zuranolone for the treatment of postpartum depression in adults—the first if its kind.
10/04/2023
FDA Alert
FDA Alert
09/15/2023
Anthony Calabro, MA
The FDA approved the new round of vaccines for those 12 years and older and authorized emergency use for children 6 months to 11 years of age.
09/15/2023
FDA Alert
FDA Alert
08/24/2023
Anthony Calabro, MA
Earlier this year, the FDA approved the same vaccine for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age and older.
08/24/2023
Arthritis
Arthritis
10/01/2020
A Janus kinase inhibitor was approved for the treatment of active polyarticular course juvenile idiopathic arthritis among patients aged 2 years or older.
10/01/2020