FDA Updates

The new indication would include adults with heart failure with a left ventricular ejection fraction (LVEF) of 40% or higher, such as mildly reduced or preserved LVEF.

Eculizumab, a humanized monoclonal antibody, was first approved for adults with generalized myasthenia gravis in 2017.

Currently, EN001 is undergoing evaluation in a phase 1b trial.

The treatment is currently undergoing evaluation in an investigational preclinical program and is projected to be in human trials in 2026.

The treatment's expanded indication for chronic kidney disease (CKD) is expected to be available by April 2025.

With the new designation, OpCT-001 can receive expedited investigations into its potential to improve vision function in patients with primary photoreceptor diseases.

The approval is based on results from 2 phase 3 clinical trials that showed revakinagene taroretcel’s efficacy in macular telangiectasia type 2 (MacTel).

The move is expected to expand clozapine access for patients with schizophrenia.

According to a news release, this marks the first significant innovation in epinephrine delivery for this patient population is more than 35 years.

The designation was granted after positive results from the phase 1 STOMP-I clinical trial (NCT01915927).

The FDA is issuing new changes to labels on testosterone products, clarifying that there are no increases in major cardiac events among men with hypogonadism but noting an increase in blood pressure with the use of such products.

The t:slim X2 insulin pump and Tandem Mobi system both use Control-IQ.

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.

Pharmacies could still experience localized availability issues for semaglutide despite its removal from the drug shortage list.

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.