Product Approvals and Launches

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.

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.

The FDA has approved oveporexton (Orzeyful), the first orexin agonist for narcolepsy type 1, based on phase 3 data showing broad symptom improvement.

Swarup Kumar, MD, of UConn Health, says iberdomide plus dara-dex fills a niche for relapsed disease in patients who lack access to CAR T or bispecifics.

The third-gen PCKS9 inhibitor was approved in December 2025 as adjunctive treatment alongside diet and exercise for adults with hypercholesterolemia.

She frames the IberDd approval as more than the addition of 1 more regimen to a crowded relapsed/refractory myeloma armamentarium.

The cereblon E3 ligase modulator, or CELMoD, also received a breakthrough therapy designation from the FDA.

The FDA approved Viatris' Gwyn Lo, a once-weekly low-dose estrogen (20 mcg) contraceptive patch, based on phase 3 LUMINOUS data showing a Pearl Index of 4.14 pregnancies per 100 woman-years and strong adhesion (98.7% intact). It's approved for women with BMI under 30; common side effects included application-site irritation and intercycle bleeding. Available later in 2026.

All from July, these 5 novel therapeutics each claimed a “first” in their category.

Accelerated approval is granted to RP1 plus nivolumab for advanced melanoma after PD-1 failure, following a nail-biting FDA approval process.

Moderna’s mRNA flu vaccine receives FDA approval after phase 3 data showed improved efficacy compared with standard flu vaccines.

Novartis says it can deliver doses to treatment sites with 5 days of order.

The FDA approval of atacicept introduces the first BAFF/APRIL dual inhibitor for IgA nephropathy, with trial data showing significant proteinuria reduction.

An FDA committee voted 9-3 that available data did not provide substantial evidence of effectiveness for deramiocel in DMD.