Product Approvals and Launches

FDA granted accelerated approval to dostarlimab-gxly for dMMR or MSI-H locally advanced rectal cancer based on interim phase 2 AZUR-1 results.

Phentolamine 0.75% (Ryzumvi) won FDA approval for presbyopia based on the phase 3 VEGA-2 and VEGA-3 trials.

Satralizumab, a first-in-class IL-6 receptor inhibitor, was approved for adults with thyroid eye disease based on the phase 3 SatraGO program.

Sagar Lonial, MD, lead investigator of the phase 3 EXCALIBER trial, dissects iberdomide data he presented at IMS 2026 and where mezigdomide fits in.

Zidesamtinib offers better tolerability in ROS1-positive NSCLC, but adverse effects still need monitoring, and optimal sequencing remains unclear.

Teva's Weltruza, a once-monthly subcutaneous olanzapine injection, requires no loading doses, oral supplementation, or postinjection monitoring.

The FDA approves atezolizumab with a fluoropyrimidine and oxaliplatin as adjuvant therapy for stage III dMMR colon cancer based on the ATOMIC trial.

Remibrutinib (Rhapsido; Novartis) is the only treatment with approved uses in both chronic spontaneous urticaria and symptomatic dermographism.

FDA approved tucatinib maintenance for HER2-positive metastatic breast cancer following induction therapy based on the 654-patient HER2CLIMB-05 trial.

The Autus Size-Adjustable Valve, which can be expanded as children grow, may reduce the need for repeat open-heart surgeries for congenital defects.

This moves the noncovalent BTK inhibitor into the first-line setting for certain adults with chronic lymphocytic leukemia or small lymphocytic lymphoma.

In the US alone, 1.1 million individuals are living with the progressive neurodegenerative movement disorder, and 90,000 are diagnosed each year.

Baricitinib is now FDA approved for adolescents 12 and older with severe alopecia areata, extending the once-daily pill beyond adults.

The regulatory decisions reflect how advances in biomarkers and molecular medicine are reshaping both diagnosis and treatment.

The FDA has approved belzutifan plus lenvatinib for advanced ccRCC after PD-1/PD-L1 therapy, expanding treatments for those with disease progression.

Imlunestrant plus abemaciclib doubled median PFS in patients with ESR1-mutated advanced breast cancer.

Rebisufligene etisparvovec-hopf (Fayuvi; Ultragenyx) is a 1-time gene therapy that addresses the underlying cause of Sanfilippo syndrome type A.

Finerenone is the first new FDA-approved treatment in more than 30 years for adults with CKD associated with type 1 diabetes.

Ann Marie Navar, MD, PhD, on enlicitide's 60% LDL reduction, less than 50% ApoB lowering, fasting dosing rules, and how it compares with inclisiran.

The FDA cleared PrecivityAD2, a blood test from C2N Diagnostics that helps diagnose Alzheimer disease in adults as young as 40.

Five August FDA approvals introduced novel therapies across vaccines, neurology, oncology, myeloma, and dermatomyositis, despite some regulatory pushback.

The action comes after an advisory panel recommended against approval, saying evidence from the did not support a “clinically meaningful benefit."

Andrew Kuykendall, MD, lead investigator for the VERIFY trial supporting the approval, said rusfertide is used to treat erythrocytosis in polycythemia vera.

Ropeginterferon alfa-2b-njft is expected to be available immediately.

FDA approves rusfertide, a first-in-class hepcidin-mimetic for polycythemia vera, cutting phlebotomies and improving hematocrit control and QOL.

FDA approves brepocitinib, the first oral, targeted therapy for adult dermatomyositis, backed by phase 3 VALOR data.

Zidesamtinib offers a new second-line option for ROS1-positive NSCLC, with durable responses and strong activity against brain metastases.

The FDA approved daraxonrasib, the first targeted therapy for metastatic pancreatic adenocarcinoma, citing a survival benefit vs chemotherapy.