Five FDA decisions that could change practice

The second half of 2026 could bring several FDA drug approvals with the potential to reshape care. From obesity and hypertension to influenza, HIV, and gastroesophageal cancer, these therapies could introduce new mechanisms, simplify treatment, and establish new standards of care. Here's what each one could mean for practice.

CagriSema: Dual-target obesity therapy

CagriSema combines semaglutide with cagrilintide, an amylin analog, in a once-weekly injection to target two complementary appetite pathways. In the phase 3 REDEFINE 1 trial, patients lost 20.4% of body weight at 68 weeks compared with 15.0% with semaglutide alone.

Why it matters: Current GLP-1 therapies have transformed obesity treatment, but many patients still need greater weight loss to meaningfully improve obesity-related complications. By targeting both GLP-1 and amylin pathways, CagriSema could raise the bar for medical weight loss.

Lorundrostat: First new antihypertensive mechanism in years

Lorundrostat selectively inhibits aldosterone synthase, lowering aldosterone production without directly blocking the mineralocorticoid receptor. In phase 3, it significantly reduced blood pressure in patients with uncontrolled or resistant hypertension who were already receiving multiple antihypertensive medications.

Why it matters: Resistant hypertension remains common despite the availability of multiple drug classes, leaving many patients above target blood pressure. By targeting excess aldosterone production, lorundrostat could offer a new option for patients who remain uncontrolled on standard therapy.

mRNA-1010: First mRNA flu vaccine

This quadrivalent mRNA influenza vaccine demonstrated 26.6% relative efficacy over licensed standard-dose influenza vaccines in a phase 3 trial of more than 40,000 adults aged 50 years and older.

Why it matters: Unlike traditional flu vaccines, mRNA vaccines do not require growing viruses in eggs and can be updated more quickly. These advantages could improve how closely the vaccine matches circulating influenza strains and provide better protection, particularly in seasons when the selected strains are a poor match.

Bictegravir/lenacapavir: First NRTI-free single-tablet HIV regimen

This novel regimen combines the integrase inhibitor bictegravir with the first-in-class capsid inhibitor lenacapavir, eliminating the need for nucleoside reverse transcriptase inhibitors. In the phase 3 ARTISTRY-1 and ARTISTRY-2 trials, bictegravir/lenacapavir maintained viral suppression through 48 weeks after switching from either complex regimens or Biktarvy.

Why it matters: The first NRTI-free one-pill regimen would provide an important alternative for patients with NRTI-related renal or bone toxicities while simplifying therapy for many virologically suppressed individuals. It could mark the beginning of a broader shift toward NRTI-sparing maintenance treatment.

Ziihera: New first-line standard for HER2-positive gastroesophageal cancer

Already approved for HER2-positive biliary tract cancer, Ziihera (zanidatamab) is a bispecific antibody that binds two distinct HER2 epitopes. In the phase 3 HERIZON-GEA-01 trial, zanidatamab plus chemotherapy improved overall survival to 26.4 months versus 19.2 months with trastuzumab plus chemotherapy in first-line HER2-positive gastroesophageal cancer.

Why it matters: Zanidatamab could replace trastuzumab as the HER2-directed backbone in first-line gastroesophageal cancer, representing the first major change in HER2-targeted treatment for this disease in more than a decade.