Product Approvals and Launches

The FDA expanded approvals for key medications, enhancing treatment options for atopic dermatitis, inflammatory bowel disease, type 2 diabetes, and more.

The FDA has approved pembrolizumab and enfortumab vedotin for muscle-invasive bladder cancer (MIBC), offering new hope for patients ineligible for cisplatin.

The FDA approved selumetinib for adults with neurofibromatosis type 1 and symptomatic, inoperable plexiform neurofibromas based on the KOMET trial.

The accelerated approval was based on a study that evaluated the efficacy in unresectable or metastatic nonsquamous NSCLC.

Plozasiran gains FDA approval as the first treatment for familial chylomicronemia syndrome based on phase 3 PALISADE data.

The FDA approved epcoritamab with rituximab and lenalidomide for relapsed follicular lymphoma, offering a promising fixed-duration treatment option for patients after their first relapse.

The FDA approved ziftomenib for relapsed acute myeloid leukemia with NPM1 mutations, offering hope for high-risk patients.

Raj Chovatiya, MD, PhD, MSCI, explains how addressing the most burdensome components of chronic hand eczema can improve overall health.

The FDA approved daratumumab and hyaluronidase-fihj (Darzalex Faspro), offering a new treatment for high-risk smoldering multiple myeloma.

Clinical trials show significant symptom improvement and potential for remission, with a safety profile similar to placebo.

The FDA has expanded sotatercept's indications for pulmonary arterial hypertension, following data showing significant drops in hospitalization and mortality risks.

The FDA approved revumenib for relapsed/refractory (R/R) acute myeloid leukemia, offering a new targeted therapy option for patients with NPM1 mutations.

Elinzanetant offers a new hormone-free solution for managing menopause-related hot flashes, targeting the root cause of vasomotor symptoms.

This timeline highlights 5 key dates in September when the FDA approved treatments for cancers, dermatologic conditions, and rare diseases.

Belantamab mafodotin provides a community-friendly BCMA-directed therapy option for relapsed/refractory myeloma, says Hearn Jay Cho, MD, PhD.

The FDA has approved belantamab mafodotin for third-line or later multiple myeloma based on DREAMM-7 trial data.

The 7-mg and 14-mg oral semaglutide tablets are now indicated to reduce the risk of major adverse cardiovascular events in adults with diabetes.

Tezepelumab (Tezspire) improves symptoms, reduces surgery needs, and lowers steroid use in patients with chronic rhinosinusitis with nasal polyps (CRSwNP).

Roflumilast 0.05% cream significantly reduces itch and improves atopic dermatitis in young children, explains Lawrence F. Eichenfield, MD.

The new indication allows doctors to use upadacitinib before tumor necrosis factor–blocking agents when those treatments are clinically inadvisable.

A new drug application for Dasynoc, a lower-dose, bioequivalent formulation of dasatinib, was not approved for patients with chronic myeloid leukemia and acute lymphoblastic leukemia.

Raj Chovatiya, MD, PhD, MSCI, describes how delgocitinib offers a long-term solution for chronic hand eczema, transforming treatment beyond traditional corticosteroids.

Cemiplimab has been approved as the first immunotherapy for high-risk cutaneous squamous cell carcinoma (CSCC), significantly improving disease-free survival rates.

The approval is the first in more than a decade for an idiopathic pulmonary fibrosis treatment.

Rilzabrutinib (Wayrilz; Sanofi) may improve immune thrombocytopenia (ITP) outcomes, enable early intervention, and enhance patient quality of life.

Roflumilast cream 0.05% gains FDA approval for young children, offering a safe, effective treatment for mild to moderate atopic dermatitis.

FDA approvals since the last Skin of Color Update expand topical and biologic options for various dermatological conditions, benefiting patients with skin of color.

The FDA has approved a second generic version of oral mifepristone, used to terminate pregnancy, after determining it is identical to the branded drug.

The approval of remibrutinib for patients with chronic spontaneous urticaria was supported by data from the phase 3 REMIX-1 and REMIX-2 clinical trials.

Raludotatug deruxtecan (R-DXd) earned FDA breakthrough designation for CDH6-expressing platinum-resistant ovarian cancers after bevacizumab (Avastin; Genentech) treatment.