FDA Updates

The autoinjector provides an accessible, at-home option for patients with chronic kidney disease or heart failure who need treatment for fluid buildup.

GSK's next-generation ROS1 inhibitor earns approval after demonstrating durable responses in the ARROS-1 trial, including among patients with brain metastases.

The new drug application's submission is supported by data from the phase 3 clinical studies SynAIRgy and LunAIRo.

The 20-mg once-daily tablet is indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C).

If approved, AXS-12 would be a potentially valuable new option for a symptom that significantly impairs the daily functioning of those with narcolepsy.

The approval of the drug combination is supported by findings from the phase 3 VIKTORIA-1 clinical trial.

Selpercatinib received approval for adults and children 2 years and older with previously treated or treatment-refractory RET fusion–positive solid tumors.

This approval marks the first time patients can begin treatment with home administration either by themselves or their caregiver.

The regimens are pembrolizumab plus enfortumab vedotin-ejfv (EV) and pembrolizumab with berahyaluronidase alfa-pmph and EV.

Ennumo is approved for the same indications as its reference product, Neulasta (pegfilgrastim).

FDA grants accelerated approval to atacicept-vymj for IgA nephropathy proteinuria, backed by ORIGIN clinical trial results.

The FDA expanded Casgevy’s indication to include children 2 years and older with sickle cell disease with recurrent VOCs or transfusion-dependent β-thalassemia, making it the first gene therapy approved for patients as young as 2 years with SCD.

Tregzi is indicated in matched-donor hematopoietic stem cell transplantation with a myeloablative preparative regimen for hematopoietic and immunologic reconstitution and to improve chronic graft-vs-host disease–free survival.

The FDA clears roflumilast, a PDE4 inhibitor, for once-daily steroid-free plaque psoriasis care in kids ages 2+.

The approval adds a 55-mg prefilled syringe for weight-based dosing and makes risankizumab the first IL-23 inhibitor cleared for pediatric patients weighing less than 40 kg.

Veligrotug-vvze is the first FDA-approved thyroid eye disease treatment with data in both active and chronic disease.

Priority review NDA puts oral SERD giredestrant on PDUFA track for ER-positive, HER2-negative breast cancer, after reduced recurrence risk in lidERA trial.

Supported by improved progression-free survival outcomes in the phase 3 ASCENT-03 and ASCENT-04/KEYNOTE-D19 trials, sacituzumab govitecan-hziy received FDA approval as both a monotherapy and combination therapy with pembrolizumab.

The FDA grants fast track designation to VS-7375, an oral KRAS G12D dual ON/OFF inhibitor, advancing new hope for pretreated non–small cell lung cancer (NSCLC).

The agent is to be used alongside diet adjustments in adult patients.

The FDA approved palbociclib-based maintenance therapy for HR-positive, HER2-positive advanced breast cancer following a significant progression-free survival benefit in PATINA.

The new indication is for patients aged 12 and older with unresectable or metastatic SS who received prior chemotherapy and are positive for various genetic subtypes.

The Moderna mRNA influenza vaccine won the FDA panel vote, but ACIP turmoil and a legal fight could threaten its fall 2026 rollout.

With this approval, Capvaxive is the only PCV specifically indicated and studied in the US for use in this patient population.

FDA approval of the first generic version of baloxavir marboxil brings an affordable single-dose flu treatment, boosting access for the 2026-27 influenza season.

FDA approval expands Breztri Aerosphere from COPD to asthma, offering single-inhaler triple therapy for adults and pediatric patients 12+.

The FDA approved Rextovy, a 4-mg OTC naloxone nasal spray, expanding public access to a lifesaving opioid overdose reversal medication and increasing the availability of nonprescription treatment options.

The indication is for complicated urinary tract infections (UTIs) caused by several susceptible microorganisms in adults who have limited or no alternative oral treatment options.