Product Approvals and Launches

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.

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.

In addition to the US, high-dose nusinersen (Spinraza; Biogen) is also approved in the European Union, Japan, and Switzerland.

The FDA approval of daratumumab and hyaluronidase-fihj for high-risk smoldering MM shifts care beyond watchful waiting, notes Peter Voorhees, MD.

Subcutaneous amivantamab offers faster treatment, fewer infusion reactions, and improved convenience for patients with EGFR-mutated NSCLC, says Estelamari Rodriguez, MD, MPH.

The FDA approved higher-dose semaglutide 7.2 mg (Wegovy HD), marking the fourth drug approved under the Commissioner's National Priority Voucher pilot program.

The approval marks the first treatment for the rare disease marked by rapid and sustained weight gain caused by hypothalamic injury or dysfunction.

Patients with primary biliary cholangitis (PBC) can use linerixibat to address cholestatic pruritus, which up to 89% of patients with PBC experience.

The newly approved mosunetuzumab for relapsed/refractory follicular lymphoma improves clinic efficiency and patient experience, says Zahra Mahmoudjafari, PharmD, MBA, BCOP.

Icotrokinra is the first and only interleukin-23–targeted oral peptide approved for plaque psoriasis.

Subcutaneous mosunetuzumab simplifies the delivery of the bispecific therapy for patients with relapsed/refractory follicular lymphoma, says Zahra Mahmoudjafari, PharmD, MBA, BCOP.

Secukinumab becomes the only IL-17A inhibitor approved for this population and the first new mechanism in the indication in nearly a decade.

Beyond progression-free survival, the combination of teclistamab and daratumumab hyaluronidase-fihj showed deep clinical responses, notes Ajay K. Nooka, MD, MPH.

Phase 3 trials show deucravacitinib, the first TYK2 inhibitor approved for adults with active psoriatic arthritis (PsA), improves both joint and skin symptoms.

The FDA approved kinase inhibitors, biologics, a pancreatic cancer device, GLP-1 updates, and a new ultrarare disease pathway in February 2026.

Teclistamab had received an accelerated approval in October 2022; the combination regimen is administered subcutaneously.