Product Approvals and Launches

A newly approved inhaled insulin expands treatment options for kids with diabetes, offering an alternative to daily injections and pump systems.

The approval is based on results from MannKind's phase 3 INHALE-1 clinical trial.

Durvalumab plus BCG also marks the first new treatment in over 30 years for high-risk non–muscle-invasive bladder cancer.

The FDA approves Datroway for first-line metastatic triple-negative breast cancer in immunotherapy-ineligible patients.

Kirk Campbell, MD, discusses why FSGS is traditionally difficult to treat, the significance of the sparsentan approval, and future access needs.

Kirk Campbell, MD, sees sparsentan as the beginning of a new treatment era for FSGS, a condition that has lacked approved therapies until now.

Karilyn Larkin, MD, weighs in on how decitabine/cedazuridine/venetoclax could transform the AML treatment experience—and the new responsibilities it places on patients.

The next-generation BCL2 inhibitor is approved for adults with relapsed or refractory MCL who have received at least 2 lines of systemic treatment

Taiho submitted the supplemental new drug application in April 2025 for decitabine/cedazuridine and venetoclax, and the FDA accepted it for review in July 2025.

These indications cover HIV, type 1 diabetes, chronic hives, genetic-related hearing loss, and lupus.

This FDA approval brings the first heterobifunctional protein degrader for HER2-negative, ESR1-mutant breast cancer, improving PFS after endocrine therapy.

The therapy receives FDA approval for Alzheimer disease agitation, backed by phase 3 data showing significant symptom reduction and delayed relapse vs placebo.

Newly FDA-approved doravirine/Islatravir maintained HIV suppression in phase 3 trials with comparable safety and minimal metabolic effects.

The weekly anifrolumab autoinjector for systemic lupus erythematosus enables at-home use and improves convenience on top of standard therapy.

FDA grants lunsotogene parvec-cwha approval for OTOF-related hearing loss, delivering single-dose gene therapy gains and expanding access with free US supply.

The FDA approved dupilumab for children aged 2 to 11 years with uncontrolled CSU—the first biologic for this pediatric population.

Nicole A. Caffiero, PharmD, MBA, BCACP, concluded AMCP 2026 by highlighting key themes shaping the specialty drug market.

FDA approves doravirine/islatravir, a once-daily, 2-drug, single-tablet HIV regimen showing noninferior efficacy to standard therapies in suppressed adults.

Teplizumab-mzwv is the first disease-modifying therapy available for children as young as 1 year diagnosed with presymptomatic type 1 diabetes.

Despite high rates of grade 3/4 infection, teclistamab was granted full approval by the FDA. Ajay K. Nooka, MD, speaks on how to optimally treat this adverse effect.

Time-limited acalabrutinib plus venetoclax improves outcomes vs chemoimmunotherapy, offering the first FDA-approved all-oral fixed-duration CLL option, explains Adam Kittai, MD.

Focal segmental glomerulosclerosis can lead to protein leakage in urine and hypertension; the condition is not considered curable at present, only manageable.

Ajai Chari, MD, discusses the teclistamab-daratumumab approval, highlighting durable remissions, infection management, and the need for community oncologist uptake.

The FDA's March 2026 approvals marked significant regulatory milestones across multiple disease states.

Adults can undergo CAR T-cell therapy for relapsed or refractory mantle cell lymphoma after the full approval of the treatment.

FDA approves Eli Lilly's orforglipron (Foundayo), the first GLP-1 obesity pill with no food or water restrictions.

The FDA now permits outpatient monitoring for epcoritamab’s first full dose in R/R DLBCL, as EPCORE-NHL-6 data support safe bispecific antibody access.

Insulin icodec-abae (Awiqli; Novo Nordisk) is now approved for use in the US, Canada, European Union, Switzerland, and 12 other countries.