FDA Updates

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.

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.

As experts in medication management and health education, pharmacists can work with the administration to promote effective strategies that reduce misinformation and improve public health outcomes.

Durvalumab could offer further treatment for individuals with muscle-invasive bladder cancer.

Fabry disease is a rare lysosomal disorder that causes excessive deposition of lipids in tissues.

Zenocutuzumab-zbco is a bispecific antibody that targets and binds to HER2 and HER3.

The indication is for adults with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed after platinum-based chemotherapy and radiation therapy.

Sacituzumab tirumotecan (sac-TMT; Kelun Pharmaceutical, Merck) is currently being studied to treat non-small cell lung cancer (NSCLC) in the TroFuse-004 and TroFuse-009 trials.

E-cigarette manufacturers claim the products aid in smoking cessation for adults without the risk of adolescent usage.

If approved, the new indications include children 6 years and older with moderate to severe plaque psoriasis and children 5 years and older with active juvenile psoriatic arthritis.

The biosimilar is approved for the treatment of Crohn disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis.

The approval is based on clinical studies that demonstrate the management of heart rate with minimal reductions to blood pressure.

Oral phenylephrine is a common ingredient in OTC products, but its clinical efficacy is questionable. The FDA is considering removing it from the market.

This is the first oral liquid form of imatinib (Imkeldi; Shorla Oncology) to be approved to treat cancers.

Acoramidis is a novel, highly potent transthyretin stabilizer.

Familial chylomicronemia syndrome (FCS) currently has no FDA-approved treatment and is associated with an increased risk of acute pancreatitis.

If approved, RAG-21 can offer improved outcomes in patients with amyotrophic lateral sclerosis (ALS), particularly those with aggressive subtypes.