FDA Updates

OraQuick was the first at-home HIV test kit to be approved by the FDA in 2012.

The new approval continues to expand the therapeutic potential of GLP-1 medications such as tirzepatide, now being deemed effective in patients with obstructive sleep apnea.

Vanzacaftor/tezacaftor/deutivacaftor (Alyftek) also received approval for the treatment of cystic fibrosis in people 6 years and older who have at least 1 F508del mutation.

Setmelanotide is indicated to reduce excess body weight and maintain weight reduction long-term for patients with syndromic or monogenic obesity due to Bardet-Biedl syndrome.

The decision is based off favorable results from the BREAKWATER trial.

Compounding pharmacies have a 60- to 90-day grace period to complete production as it continues to monitor supply and demand.

The approval follows positive results from the V005 (NCT03005418) clinical trial.

The rare genetic disease is a severe hypertriglyceridemia that can lead to potentially life-threatening acute pancreatitis.

Duloxetine is a commonly prescribed medication used to treat anxiety, depression, and other mental health disorders.

The indication is for patients with locally advanced or metastatic disease who have not previously received treatment with an ALK-inhibitor.

The approval makes remestemcel-L-rknd the first approved mesenchymal stromal cell in the United States.

Lerodalcibep is a third-generation PCSK9 inhibitor that demonstrated success in reducing low density lipoprotein cholesterol (LDL-C).

Clesrovimab would be the first and only single dose immunization indicated for infants regardless of weight, aimed to protect against their first RSV season.

The updated prescribing information recommends laboratory tests prior to prescribing fezolinetant to determine baseline for hepatic function and injury.

Ustekinumab-stba (Steqeyma; Celltrion) is a subcutaneous treatment for adult and pediatric patients with plaque psoriasis arthritis, psoriatic arthritis, Crohn disease, and ulcerative colitis.

If approved, cyclobenzaprine hydrochloride (HCl) will be the first member of a new class of analgesic drugs for fibromyalgia.

The decision is based on positive results from the CAHtalyst trials, which both met their primary and secondary end points.

Abstract data presented in September demonstrate that the drug elicited strong antitumor activity in the second line in both platinum-sensitive and -resistant patients.

Based on positive results from the HERCULES trial, the new designation will allow for more thorough regulatory review and development of the multiple sclerosis treatment.

Nemolizumab exclusively targets IL-31 receptor alpha, inhibiting the signaling of IL-31, which drives disease mechanism in atopic dermatitis.

The indication is for adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or radiation.

The approval builds on previous indications for tapinarof, an aryl hydrocarbon receptor agonist, for the topical treatment of atopic dermatitis.

The treatments are currently undergoing evaluation in the SOLSTICE trial (NCT05461170).

The pumps can now be used to treat pediatric patients who have symptomatic acute decompensated heart failure and cardiogenic shock.

Currently, the treatment is undergoing evaluation in a phase 2a trial.

This update follows May 2021 guidelines which recommended patients with primary biliary cholangitis (PBC) with advanced cirrhosis discontinue obeticholic acid.

The combination vaccine candidates will be evaluated in 2 separate phase 1/2 clinical trials.

PLT012 demonstrates its potential against multiple tumors with unmet medical needs.

Two studies found a 2-bag regimen of N-acetylcysteine (NAC) resulted in fewer and shorter delays in treatment as well as decreases in cutaneous non-allergic anaphylactoid reactions.

If approved, the treatment will be the first and only once-daily, oral selective somatostatin receptor type 2 nonpeptide agonist available for acromegaly.