FDA Updates

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 those aged 12 years and older with unresectable or metastatic SS who received prior chemotherapy and are positive for certain 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 indication is for complicated urinary tract infections (UTIs) caused by several susceptible microorganisms in adults who have limited or no alternative oral treatment options.

The integrated CGM is now indicated for individuals 2 years and older who do not use insulin.

Approval of teplizumab-mzwv in patients aged 8 to 17 years makes it the first disease-modifying therapy for children newly diagnosed with stage 3 type 1 diabetes.

Korean and Asian manufacturers have used bemotrizinol widely in sunscreen formulations for many years.

The indication is for adults with PTEN-deficient metastatic androgen pathway modulation-naïve or modulation-sensitive prostate cancer.

Vertanical's investigational cannabis-derived therapy VER-01 received FDA breakthrough therapy designation after positive phase 3 data demonstrated significant pain reduction and improved tolerability in patients with chronic low back pain.

The FDA approved the oral antiviral ensitrelvir (Xocova; Shionogi & Co, Ltd) for post-exposure prophylaxis (PEP) of COVID‑19 in adults and adolescents 12 years and older.

Data presented at ASCO 2026 show giredestrant plus palbociclib extends PFS in ER+/HER2– metastatic breast cancer; FDA approval is on the horizon.

Afrezza is the only ultra rapid-acting inhaled insulin approved by the FDA to improve glycemic control in children, adolescent, and adult patients with diabetes.

FDA approval brings durvalumab plus BCG to frontline high-risk NMIBC, boosting disease-free survival and expanding oncology options.

The approval ends a decades-long gap in care for patients with chronic hepatitis delta virus (HDV) infection, a serious and life-threatening coinfection with hepatitis B that can rapidly progress to cirrhosis, liver cancer, and liver failure.

This week's episode covers the White House's expansion of the TrumpRx.gov platform, the pharmacist's critical role in closing adult hepatitis B vaccination gaps, and new FDA approvals in immunology, oncology, and cardiovascular care.

If approved for this indication, finerenone would become the first nonsteroidal mineralocorticoid receptor antagonist indicated for adults with type 1 diabetes and CKD.

The approval is supported by data from the phase 3 TROPION-Breast02 trial.

New once-daily oral GLP‑1 agonist cuts hemoglobin A1c and drives 5% to 10% weight loss—with no fasting rules—expanding options for obesity and diabetes care.

The FDA approved baxdrostat based on meaningfully positive results from the phase 3 BaxHTN trial.

The FDA approved 2 new indications for fam-trastuzumab deruxtecan-nxki in HER2-positive early-stage breast cancer, expanding its use in both neoadjuvant and adjuvant settings.

FDA approval clears interchangeable golimumab biosimilars for rheumatoid arthritis and ulcerative colitis, promising lower-cost TNF therapy.

Efficacy and safety were evaluated in the phase 3 IMvigor011 trial.