Product Approvals and Launches

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 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.

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

The autoinjector delivers subcutaneous furosemide with IV-equivalent exposure in under 10 seconds for adults with heart failure or CKD-related edema.

June 2026 brought 5 FDA firsts across infectious disease, oncology, and rare disease, expanding treatment options and addressing unmet patient needs.

FDA approves zidesamtinib for ROS1-positive NSCLC after prior TKIs, offering a new option for resistant and CNS-active disease.

In trials, the first oral PCSK9 inhibitor cut LDL cholesterol by up to 60%, which matched the efficacy of injectable PCSK9 therapies.

Approval is granted for patients with PIK3CA wild-type disease who progressed after endocrine therapy, based on VIKTORIA-1's improved survival results.

Veligrotug is a newly FDA-approved treatment that can target the proptosis associated with thyroid eye disease.

FDA clears perioperative Keytruda + Padcev for all patients with muscle-invasive bladder cancer, establishing a new cisplatin-independent standard of care.

The first half of 2026 saw the FDA approve 5 notable first-in-class therapies across obesity, AML, kidney disease, hearing loss, and bladder cancer.

Vera's atacicept (Trutakna) wins FDA accelerated approval after a 46% proteinuria drop in the ORIGIN 3 trial.

FDA approves Orca-T precision Treg cell therapy for matched donor transplants, cutting chronic GVHD risk and boosting survival in blood cancers.

Rrisankizumab is the first and only IL-23 inhibitor FDA-approved for children aged 6 and older under 40 kg with plaque psoriasis or psoriatic arthritis.

Veligrotug-vvze (Lumvoa; Viridian Therapeutics) is the first treatment for thyroid eye disease (TED) that has been approved by the FDA with labeling that includes data for both active and chronic TED.

The FDA approved sacituzumab govitecan-hziy alone or with pembrolizumab as first-line therapy for metastatic triple-negative breast cancer.

FDA approves palbociclib (Ibrance) for HR+, HER2+ metastatic breast cancer maintenance, based on phase 3 PATINA data showing a 24% reduction in progression risk.

FDA approval of generic rifapentine introduces a new option for treating active tuberculosis and preventing progression of latent infection.

The FDA approved the first oral carbapenem, tebipenem pivoxil, for complicated UTIs, offering an alternative to intravenous therapy.

Peter Hotez, MD, discusses which patients may benefit most from newly approved oral COVID-19 postexposure prophylaxis.

The FDA's first new sunscreen ingredient approved in nearly 3 decades is set to reshape the US market. Here is what dermatologists need to know.