Product Approvals and Launches page will cover the latest FDA product approvals, as well as product launches in the United States.

Articles

The gene therapy is the first treatment for active cerebral adrenoleukodystrophy, a fatal neurodegenerative disease that affects boys.

bluebird bio Receives FDA Accelerated Approval for Rare Brain Disease Gene Therapy

An estimated 1 in 4 patients treated with durvalumab and chemotherapy (gemcitabine plus cisplatin) was alive at 2 years compared with 1 in 10 treated with chemotherapy alone, with these results contributing to the FDA's approval of the first immunotherapy to treat these cancers.

Durvalumab With Chemo Wins FDA Approval in Treatment of Biliary Tract Cancers

The FDA Friday approved pemigatinib (Pemazyre), a selective fibroblast growth factor (FGFR) inhibitor, to treat adults who have relapsed or refractory (R/R) myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement, a very rare and aggressive cancer.

FDA Approves Pemigatinib for Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement

The FDA Wednesday approved betibeglogene autotemcel (Zynteglo), the first cell-based gene therapy for the treatment of adult and pediatric patients with beta-thalassemia who require regular red blood cell transfusions. 

FDA Approves First Gene Therapy for Beta-thalassemia

Darolutamide, sold as Nubeqa, is an androgen receptor inhibitor, which works to limit prostate cell growth by preventing the binding of hormones, or androgens, to proteins known as androgen receptors.

FDA Approves Darolutamide Combo for Metastatic Hormone-Sensitive Prostate Cancer

The approval came exactly 2 months after results from the landmark DESTINY-Breast04 trial showed that the antibody drug conjugate reduced the risk of disease progression or death by 50% compared with chemotherapy for HER2-low patients with both hormone receptor (HR)–positive and HR-negative disease.

Trastuzumab Deruxtecan Wins Rapid Approval for HER2-Low Breast Cancer

Ruxolitinib (Opzelura) cream is the first and only FDA-approved treatment for repigmentation in patients with vitiligo. 

FDA Approves Ruxolitinib Cream as First Repigmentation Therapy for Vitiligo

Pegloticase (Krystexxa) injection coadministered with methotrexate received FDA approval for the treatment of gout. 

FDA Approves Pegloticase Injection Coadministered With Methotrexate for Gout

The combination is the first and only therapy to be approved with a tumor-agnostic indication in both children and adults with solid tumors that have a BRAF V600E mutation, Novartis said late Wednesday.

Dabrafenib Plus Trametinib Approved as First Tumor-Agnostic Therapy for BRAF V600E–Mutated Solid Tumors

The FDA approval for Fylnetra represents the fifth approval for a biosimilar referencing Neulasta (pegfilgrastim) in the United States.