FDA Updates

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.

The subcutaneous infusion is indicated for pediatric patients aged 6 to 17 years who weigh less than 60 kg.

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.

Following a meeting of the Vaccines and Related Biological Products Advisory Committee, the FDA announced its recommendation of COVID-19 vaccines targeting LP.8.1, a strain of the JN.1 variant that has become dominant in the US.

The approval is based on findings from the INSPIRE trial, where treprostinil demonstrated efficacy in pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).

This indication is for adult and pediatric patients aged 12 and older with plaque psoriasis of the scalp and body.

Mepolizumab gains FDA approval as a promising add-on therapy for COPD patients with eosinophilic phenotype, reducing exacerbation rates significantly.

Ranibizumab injection (Susvimo; Genentech) could offer long-lasting vision preservation and reduce the need for frequent injections in patients with diabetic retinopathy.

Yuflyma gains FDA interchangeability with Humira, enhancing patient access to effective biosimilar treatments for various inflammatory conditions.

In a major policy shift, officials from the FDA announced a new regulatory framework for COVID-19 vaccinations, prioritizing adults 65 years and older and individuals with serious comorbidities putting them at high risk for severe COVID-19.