FDA Updates

GLSI-100 shows promise in preventing HER2-positive breast cancer recurrence after standard therapy.

Explore recent FDA-approved drugs from August 2025.

Selumetinib gains expanded FDA approval for younger pediatric patients with neurofibromatosis type 1 plexiform neurofibromas, enhancing treatment options and addressing significant disease-related challenges.

The FDA approves a groundbreaking gemcitabine system, offering new hope for patients with BCG-unresponsive bladder cancer.

FDA expands Vonvendi use for von Willebrand disease (VWD), enhancing treatment options for adults and children to manage bleeding effectively.

The FDA designates olomorasib as a breakthrough therapy, enhancing treatment options for advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutations.

FDA approves a new extended-release suspension formulation of risperidone for schizophrenia, expanding treatment options for patients.

Zongertinib promises significant advancements in patient care.

This decision is believed to redefine how biological drugs will be developed, approved, and made affordable for patients.

The approval of 2 denosumab biosimilars, Bildyos and Bilprevda, enhances access to affordable bone health treatments for patients.

Rilzabrutinib gained FDA approval as the first BTK inhibitor for chronic immune thrombocytopenia, offering new hope for patients with persistent symptoms.

The subcutaneous injection for maintenance treatment enhances accessibility and reduces infusion time for patients.

The FDA has approved a ready-to-use long-acting injectable formulation that is administered every 3 months as a treatment for advanced prostate cancer.

The action is supported by 3 ongoing clinical trials, which are evaluating izalontamab brengitecan (iza-bren) in non–small cell lung cancer (NSCLC) and other diseases.

Allison Hill, PharmD, RPh, emphasized that pharmacists must stay updated on ACIP and state-level guidance following HHS’s changes to COVID-19 vaccine authorizations.

The FDA updated sparsentan's REMS, easing monitoring requirements, enhancing treatment access for IgA nephropathy patients, and supporting kidney function preservation.

Generic liraglutide injection is the first GLP-1 indicated for weight loss.

Orforglipron is an effective treatment, leading to significant body weight reduction and improved glycemic control.

The FDA suspended the biologics license for Ixchiq, the first approved chikungunya vaccine, after reports of serious adverse events and fatalities.

The action follows phase 3 trial data that demonstrated reduced phlebotomy dependence, improved hematocrit control, and eased symptoms.

Evolocumab is now indicated for adults at increased risk for major adverse cardiovascular events (MACE).

The FDA approves donidalorsen, the first RNA-targeted therapy for hereditary angioedema, offering significant attack reduction and convenient administration.

Signos CGM empowers users to manage weight effectively through personalized insights and real-time glucose tracking.

The complete response letter (CRL) stated that vatiquinone's new drug application (NDA) did not provide substantial evidence of efficacy and would need to be evaluated in a new trial.

Plozasiran significantly reduces triglyceride levels and pancreatitis risk in FCS patients, offering hope for effective treatment options.

FDA approves a new liquid formulation of losartan for hypertension treatment, enhancing accessibility for adults and children over 6 years old.

FDA approves semaglutide for treating MASH, offering new hope for affected individuals.

FDA approves Tonmya, the first new fibromyalgia treatment in 15 years, offering hope for effective pain relief and improved quality of life.

The designation is supported by promising results from the ongoing phase 1/2 BEACON clinical trial.

Brensocatib emerges as the first FDA-approved treatment for non-cystic fibrosis bronchiectasis, revolutionizing care and targeting chronic inflammation.