FDA Updates

The action follows pooled data from 2 studies that enrolled patients with hemophagocytic lymphohistiocytosis (HLH)/macrophage activation syndrome (MAS) in Still disease.

The new approval expands the portfolio of denosumab biosimilars, increasing access and improving costs for patients.

The decision is based on clinically meaningful results from a phase 3 trial.

ADI-101 targets CD20 for the treatment of autoimmune diseases and is advancing across 6 autoimmune indications.

In a clinical trial, tenecteplase was shown to be a comparable alternative to alteplase.

The decisions were made amid the United States worst flu outbreak in over 2 decades.

The feature is expected to be available to US users in late March 2025.

The advanced therapy yielded superior enhanced mucus secretion compared with available therapies.

The updated indication now includes pediatric patients aged 5 through 11 years.

The newly-approved intrauterine device (IUD) prevents pregnancy in people of reproductive potential for up to 3 years.

Pembrolizumab is a humanized monoclonal antibody that targets PD-1.

The label changes to buprenorphine extended-release injections can increase convenience and adherence for patients with moderate to severe opioid use disorder.

The designation is supported by pooled data from 4 clinical trials.

The test results are available in as little as 20 minutes.

Currently, the agent is undergoing evaluation in a phase 2 clinical trial to determine its safety and efficacy.

SkinTE could aid Wagner grade 1 diabetic foot ulcers by regenerating and activating the tissues surrounding the wound to heal it completely.

This marks the first FDA-approved treatment for this rare lipid storage disease.

67Cu-SAR-bisPSMA is indicated for adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC).

Priority review status will allow for expedited development of zongertinib, putting it on the path toward approval as the first in a new class of drugs for mutated NSCLC.

The approval in multiple indications is designed to improve access to effective, proven treatments for skeletal fractures, which can greatly reduce patient quality of life.

Invasive meningococcal disease is a severe bacterial infection caused by the bacterium Neisseria meningitidis, often leading to meningitis or sepsis.

Amlenetug could provide a treatment option for patients with multiple system atrophy, a progressive and rare condition that causes damage to the brain’s nerve cells.

Insulin-aspart-szjj (Merilog) is the first rapid-acting insulin biosimilar product approved by the FDA.

The indication is for symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity.

PP-01 could become a first-in-class treatment for patients with cannabis use disorder.

Currently, the Cadherin-6 targeting antibody-drug conjugate is undergoing evaluation in a phase 1a/1b clinical trial.

The agency will now review the novel PCSK9 inhibitor for possible approval in patients with or at high risk of atherosclerotic cardiovascular disease.