Product Approvals and Launches

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.

The approval of paltusotine (Palsonify; Crinetics) marks the first for a once-daily, oral therapy to treat acromegaly.

FDA approved the monotherapy for estrogen receptor (ER)–positive and HER2-negative metastatic breast cancer.

Leucovorin is under FDA review to expand treatment for children with cerebral folate deficiency, which has been assciated with autism.

The approval allows all patients 12 years and older to use pembrolizumab and berahyaluronidase alfa-pmph for subcutaneous injection for solid tumor indications approved for intravenous pembrolizumab.

Ruxolitinib cream received an expanded approval to treat patients as young as 2 years old with non-immunocompromised mild to severe atopic dermatitis.

From respiratory conditions to rare diseases and beyond, here are 5 groundbreaking FDA approvals from last month.

FDA expands selumetinib approval to younger children with NF1-related tumors.

A new FDA-approved blood test for Alzheimer disease could transform diagnosis and treatment accessibility, according to this conversation with Howard Fillit, MD, and Anthony “Nino” Sireci, MD, MSc.

The FDA has approved rilzabrutinib (Wayrilz; Sanofi) as a groundbreaking treatment for immune thrombocytopenia (ITP), enhancing patient outcomes and quality of life.