FDA Updates

Suzetrigine, a new nonopioid pain reliever, gains FDA approval for treating moderate to severe acute pain in adults, offering a safer alternative to opioids.

Compared with prior intravenous formulations, the autoinjector is a more accessible administration method for children and their caregivers.

Datopotamab deruxtecan gains FDA approval, offering new hope for adults with advanced EGFR-mutated non-small cell lung cancer after prior therapies.

The FDA approves dupilumab as the first targeted treatment for bullous pemphigoid, offering hope for patients with this debilitating skin condition.

Its approval was based on data from a 3-year trial that enrolled patients with alkaptonuria.

Following robust progression-free survival indications in the phase 3 inMIND trial, the FDA granted approval to tafasitamab-cxix in combination with standard-of-care lenalidomide and rituximab for patients with relapsed or refractory follicular lymphoma.

In the first half of 2025, the FDA approved 7 novel drugs for oncologic conditions, including for non-small cell lung cancer; ovarian cancer; and metastatic, hormone receptor-positive, human epidermal growth factor 2-negative breast cancer.

Lenacapavir becomes the first and only twice-yearly option for HIV prevention.

The FDA approves garadacimab-gxii, a treatment for hereditary angioedema (HAE), offering convenient monthly self-injections for patients 12 years and older.

Moderna's mRNA-1345 vaccine gains FDA approval, enhancing protection against RSV for high-risk adults aged 18 to 59 years, following earlier approvals for older populations.

Pembrolizumab gains FDA approval as a groundbreaking neoadjuvant treatment for resectable locally advanced head and neck squamous cell carcinoma, enhancing patient outcomes.

Mitomycin intravesical solution is the first FDA-approved treatment for low-grade intermediate-risk non–muscle-invasive bladder cancer.

The approval of the tablet formulation of zanubrutinib covers all 5 approved indications of the Bruton tyrosine kinase inhibitor.

The expansion marks glecaprevir/pibrentasvir as the first and only indicated direct-acting antiviral approved for acute hepatitis C virus (HCV) infection.

Taletrectinib demonstrated high response rates and was well tolerated among patients with ROS1+ non-small cell lung cancer (NSCLC).

Meloxicam injection gains FDA approval for effective management of moderate-to-severe pain, offering a nonopioid alternative in pain control strategies.

The FDA approves clesrovimab-cfor, a new RSV vaccine, offering infants effective protection against severe respiratory illness during their first RSV season.

The FDA has approved a groundbreaking single-pill combination therapy for hypertension, enhancing cardiovascular health with triple-agent efficacy.

The FDA has approved darolutamide for patients with metastatic castration-sensitive prostate cancer after positive results in the ARANOTE clinical trial.

Clairity Breast's FDA-approved AI platform revolutionizes breast cancer risk prediction, enhancing early detection and personalized prevention strategies.

Amid intensified scrutiny of COVID-19 vaccines at HHS, Moderna’s mRNA-1283 COVID-19 vaccine was granted FDA approval for patients 65 years and older and patients aged 12 to 64 years with at least 1 or more underlying risk factors for severe COVID-19.

The FDA designated Hadlima as an interchangeable biosimilar to Humira, enhancing patient access and potential savings for various conditions.

The FDA grants fast track designation to TEV-53408, a promising treatment for celiac disease designed to address gluten intolerance and improve patient outcomes.

The formulation allows for individualized treatment in children with adrenocortical insufficiency.

FDA approves acoltremon ophthalmic solution, a groundbreaking treatment for dry eye disease, enhancing natural tear production and patient quality of life.

The FDA approved the MenQuadfi vaccine for young children, enhancing protection against invasive meningococcal disease and its severe complications.

A new biosimilar to ustekinumab (Stelara) has been approved by the FDA, further expanding treatment options for patients with immune conditions such as plaque psoriasis and psoriatic arthritis.

The change is poised to impact countless individuals who may have sought a COVID-19 vaccine this upcoming respiratory season.