FDA Updates

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.

Setrusumab could offer a rapid and clinically meaningful decrease in fracture rate in individuals with osteogenesis imperfecta.

Nivolumab is the only PD-1 inhibitor to show statistically significant and clinically meaningful benefits in non-small cell lung cancer compared with chemotherapy.

The treatment aims to reduce prolonged QTc interval in patients with long QT syndrome.

The new screening test provides an easier, convenient option for patients seeking to screen themselves for colorectal cancer.

Currently, Danon disease has a poor prognosis and does not have any pharmaceutical therapeutics for treatment or management.

In a phase 1 trial, the nicotine replacement therapy (NRT) demonstrated a higher mean maximum plasma concentration was achieved faster than with an existing inhaled NRT.

Currently, VLS-1488 is being evaluated in a phase 1/2 trial (NCT05902988) in various advanced tumors, including high-grade serous ovarian cancer (HGSOC).

The designation was based on results from the DESTINY-Breast06 trial, evaluating fam-trastuzumab deruxtecan-nxki (Enhertu; AstraZeneca, Daiichi Sankyo) compared with chemotherapy.

Positive trial results laid the groundwork for the designation.

Navenibart was developed to aid treatment of hereditary angioedema (HAE) to provide swift and sustained HAE attack prevention through administration every 3 to 6 months.

Ustekinumab is a human monoclonal antibody targeting the cytokines interleukin (IL)-12 and IL-23, which play a rule in the inflammatory and immune responses.

MDL-101 is a proposed novel precision medicine that targets the LAMA1 gene, causing LAMA2 congenital muscular dystrophy type 1a.

The indication is for adult and pediatric patients aged 2 years and older with advanced or metastatic RET-mutated medullary thyroid cancer (MTC) who require systemic therapy.

Dupilumab is the first biologic medicine for patients with chronic obstructive pulmonary disease to be approved in the US.

Xanomeline and trospium chloride is the first in a new class, offering a new approach with selectively targeting M1 and M4 receptors.

As welcome as this compliance extension may be for those who qualify, it is critical they understand both their current and future regulatory obligations.

The approval marks the only FDA-approved stand-alone therapy for the treatment of Niemann-Pick disease type C (NPC).

The decision is based on positive results from the phase 3 LAURA trial.

Treatment is typically tailored to the individuals, with HCT being the only curative treatment bone marrow failure, but long-term outcomes are generally poorer due to toxicities.