FDA Updates

If approved, the combination regimen would be the first FDA-approved treatment for adults with recurrent KRAS mutant low-grade serous ovarian cancer (LGSOC).

If approved, the investigational intravenous gene therapy will be the first disease-modifying therapy for developmental and epileptic encephalopathy (DEE).

HLX14 (Organon) is an investigational biosimilar to denosumab (Prolia/Xgeva; Amgen).

The accelerated approval comes after 48-week major molecular response rate data.

The new indications include pediatric individuals with acute lymphoblastic leukemia and polyarticular juvenile idiopathic arthritis.

The approval marks the first and only abuse-deterrent immediate release oxycodone formulation.

Results demonstrating safety and efficacy in those with anemia in non-dialysis dependent chronic kidney disease and anemia in dialysis-dependent chronic kidney disease were presented at the 2024 American Society of Nephrology Kidney Week.

In postmenopausal women, the gel can reduce moderate to severe hot flashes as well as menopausal changes and symptoms.

Zaltenibart could be an effective treatment option for C3 glomerulopathy as the most proximal inhibitor of the alternative pathway.

The call follows the FDA’s sudden removal of tirzepatide from the drug shortage list, preventing compounding pharmacies from providing the drug.

Congenital muscular dystrophy type 1a is a severe, early-onset condition that currently has no treatment, but MDL-101 may serve as a 1-time, durable treatment option.

The FDA announces a Class II recall for the lot #220128, which were reported to contain the presence of nitrosamine.

The approval marks Abrysvo as the first and only RSV vaccine designated for adults younger than 50 that are at increased risk for LRTD.

In April 2024, the FDA approved ustekinumab-aekn as a subcutaneous injection for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis.

The diagnostic test is a companion to vorasidenib, an isocitrate dehydrogenase inhibitor that received FDA approval this past summer.

Zolbetuximab is the first approved CLDN18.2-targeted treatment for gastric and gastroesophageal junction adenocarcinoma.

The additions include Dextrose 70% intravenous (IV) solution, Lactated Ringers IV Solution, and Peritoneal Dialysis Solution, which were affected by Hurricane Helene.

Patients aged 7 years and older can now be treated for their cataplexy or excessive daytime sleepiness with the extended-release oral formulation.

This approval makes foscarbidopa/foslevodopa the first and only subcutaneous 24-hour infusion of levodopa-based therapy for adults with Parkinson disease.

Gepotidacin could be first-in-class oral antibiotic treatment approved for uUTIs in over 20 years.

Imuldosa has received approval for all indications of its reference product, including ulcerative colitis, psoriatic arthritis, and Crohn disease.

This approval marks the first and only anti-tissue factor pathway inhibitor approved in the US for the treatment hemophilia A or B, and the first approved hemophilia treatment to be administered via a pre-filled, auto-injector pen.

As the first dual neurokinin-1 and 3 receptor antagonist, elinzanetant could provide benefit for women suffering from vasomotor symptoms.

The exemption allows more time for partners to adhere to enhanced distribution security requirements in the Food, Drug, & Cosmetics Act and prevents possible supply chain disruptions.

The FDA also approved the FoundationOne Liquid CDx assay as a companion diagnostic device to identify patients who would benefit from the treatment.

The regulatory action is based on a positive preliminary analysis of the VANTAGE trial.

Healgen Rapid Check COVID-19/Flu A&B Antigen Test is the first OTC test to detect influenza to be granted a marketing authorization outside of Emergency Use Authorizations.