FDA Updates

The treatment is indicated for patients with FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancers.

The FDA recommends the dosage of givinostat (Duvyzat; Italfarmaco, ITF Therapeutics) should be based on the individual’s body weight and administered twice daily with food.

Rilpivirine (Edurant Ped; Johnson and Johnson) is indicated for the treatment of HIV in combination with other antiretroviral therapies in treatment-naïve pediatric patients.

The FDA has only approved aprocitentan (Tryvio; Idorsia) in the 12.5 mg dosage as the effects were similar between the 25 mg and 12.5 mg dosages.

The agency is looking to regulate them as medical devices.

The approval comes after positive results from the PhALLCON study, however, further research is needed to confirm immature event-free survival findings.

To date, this is the only targeted therapy indicated for the treatment of generalized pustular psoriasis.

This approval makes atidarsagene autotemcel the only therapy to be approved in the US for early-symptomatic early juvenile metachromatic leukodystrophy.

The agency will focus on collaboration to protect public health; advancing regulatory approaches; developing standards, guidelines, and best practices; and supporting research that evaluates and monitors AI performance.

The FDA-approved topical and oral agent is currently indicated for adult patients with patterned alopecia.

In a phase 1/2 clinical trial, lisocabtagene maraleucel helped patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) achieve complete response rates.

The drug is the first FDA-approved agent for treating hepatorenal syndrome.

The platform is a first-of-its-kind therapeutic approach to promote remyelination among individuals with relapsing/remitting multiple sclerosis.

LSD d-tartrate (MM-120) showed rapid improvements in patients with generalized anxiety disorder by day 2 of the study.

Results from the phase 3 RATIONALE 302 trial showed tislelizumab-jsgr prolonged survival compared to chemotherapy in patients who received prior systemic treatment.

The accelerated approval of resmetirom, a once-daily, oral thyroid hormone receptor-β agonist, is the first treatment available for patients with this disease.

The drug is indicated for patients 5 years of age and older with progressive familial intrahepatic cholestasis and cholestatic pruritus in pediatric patients with Alagille syndrome.

At 4 months, 75% of participants achieved remission and no longer showed signs of depression symptoms in a phase 2 clinical trial.

Individuals included in the study reported positive changes in fatigue, and disease activity displayed endoscopic and histologic remission.

The IVIG therapies were previously approved for 4-week room temperature storage conditions of 25º Celsius during the first 24 months of shelf life.

Semaglutide (Wegovy; Novo Nordisk) reduces the risk of cardiovascular death, heart attack, and stroke in adults with cardiovascular disease and either obesity or overweight when combined with the standard-of-care.

The FDA is convening a committee to discuss phase 3 data after the planned action date, which delays drug availability to patients.

Patients with urothelial carcinoma who were treated with the nivolumab-based regimen had better OS and PFS compared with those who received cisplatin with gemcitabine alone.

The application was previously granted fast track designation and orphan drug designation.

The designation is for all patients with low-grade serous ovarian cancer, regardless of their KRAS status and after 1 or more prior lines of therapy.

Tocilizumab-aazg (Tyenne; Fresenius Kabi) is the first approved biosimilar to tocilizumab (Actemra; Genentech) as both intravenous and subcutaneous.

They also compared the approach of the European Medicines Agency and the FDA in drug approvals.

The device conducts blood biomarker tests that accurately diagnose amyloid pathology and can assist in diagnosing Alzheimer disease in patients with cognitive impairment.