Product Approvals and Launches

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.

FDA approved Rextovy, a 4-mg OTC naloxone nasal spray, expanding access to opioid overdose reversal medications nationwide.

FDA approves ensitrelvir for COVID-19 postexposure prophylaxis following phase 3 data showing efficacy against Omicron symptoms.

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.

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.

Efgartigimod has recently been shown effective when investigated to treat ocular myasthenia gravis and juvenile myasthenia gravis.

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.