FDA Updates

The approval gives pharmacists a new nonTNF biologic option across both major forms of pediatric inflammatory bowel disease.

Pfizer and BioNTech, Moderna, Sanofi, and Takeda received FDA approval for updated 2026-2027 COVID-19 vaccines reformulated to target the XFG variant.

The combination of bictegravir and lenacapavir gives virologically suppressed adults with HIV a new option showing sustained viral suppression.

The once daily medication outperformed placebo across all 9 key secondary end points in the phase 3 VALOR trial.

The approval gives providers a second-generation integrase inhibitor to start eligible newborns with HIV-1 on therapy from birth.

The Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System will soon be available for patients 2 years and older with diabetes.

Heidi Overton, MD, PhD, was nominated to the position amid debates on abortion pill access, childhood immunization schedules, and more.

Hailey Choi, PharmD, BCAC, CDCES, Jana Murry, PharmD, RPh, and Spencer Casella, PharmD, RPh, answer key questions on GLP-1 compounding.

The expanded approval adds a self-administered autoinjector option and new label language tying LDL-C lowering to reduced cardiovascular risk.

The approval gives pharmacists a new, nonegg-based seasonal influenza option for adults 50 and older ahead of the 2026-2027 flu season.

Oveporexton, an oral orexin receptor 2 agonist, is the first medicine to restore orexin signaling rather than manage symptoms of the rare sleep disorder.

This medication is the first FDA-approved OTC innovation in the cold and flu category in 14 years.

The rapid-acting insulin aspart biosimilar adds a third interchangeable option to NovoLog, with implications for pharmacy dispensing and counseling.

Viatris' new transdermal patch adds a low-dose estrogen option to the contraceptive landscape.

The opioid-free product pairs acetaminophen with naproxen in a single dose, giving pharmacists a new counseling point for patients.

The approval is backed by pivotal phase 3 trials and carries boxed warnings for suicidal ideation in pediatric patients and abuse potential.

In the first of a 2-day hearing on peptide therapy access, the FDA votes in favor of approving 4 of the products discussed, with the potential for more on Friday.

Lipfendra (enlicitide) showed placebo-adjusted low-density lipoprotein cholesterol reductions of more than 50% in 2 phase 3 trials.

Subcutaneous lecanemab-irmb can now be self-administered or given by a caregiver from the first dose, eliminating the requirement for an initial in-clinic intravenous infusion.

Atacicept-vymj is the first medication for immunoglobulin A nephropathy that targets both B cell activating factor and a proliferation-inducing ligand inhibitors.

FDA staff review recommends against adding 7 peptides to the 503A bulk list, citing gaps in characterization, effectiveness, and safety data.

The approval extends risankizumab to children 6 years and older and introduces a new weight-based 55 mg prefilled syringe.

This approval provides pharmacists with an option for patients whose levels remain refractory to lifestyle and standard medication.

The first generic rifapentine expands affordable treatment for active and latent tuberculosis.

This episode highlights the FDA’s announcement regarding GLP-1 supply stabilization and critical compliance strategies for 503A pharmacies.

FDA advisors back Moderna’s mRNA flu shot for older adults, hinting at a potential egg-free option for 2026–2027.

The pneumococcal vaccine is approved for protection against 21 serotypes in adults over 18 and children between 2 and 17 at high risk of disease.

FDA clears first generic Xofluza tablet, bringing affordable single-dose flu treatment and prevention.