Drug Pipeline News

The decision is based on statistical significance achieved in the T2NOW trial, which demonstrated reduction of A1C.

pJIA can lead to an increased risk of permanent joint damage as well as delayed growth and development.

Once-daily, steroid-free, topical roflumilast cream 0.15% has a PDUFA date of July 7, 2024.

The 2-drug, fixed-dose combination tablet contains darunavir, an HIV-1 protease inhibitor, and cobicistat, a CYP3A inhibitor that serves as a PK enhancer or “booster.”

Additionally, a new weight-based oral solution, RINVOQ LQ, is now available as an option for the pediatric populations.

Mesoblast Limited's chief executive announced a BLA resubmission for remestemcel-L is expected to be filed with the FDA this quarter.

The maximum daily dose has increased from 80 mg to 100 mg.

Prior to the federal agency's decision, children aged 5 years and older could only receive belimumab through an intravenous (IV) formulation.

The therapy was previously granted accelerated approval for the thyroid cancer indications in adults and pediatric patients aged 12 years and older.

The once daily extended-release oral suspension with nighttime dosing is approved to treat ADHD as a monotherapy or as an adjunctive therapy to approved CNS stimulant medications.

Approximately 40% of patients who receive PN in the United States as an intravenous source of nourishment are under 18 years of age.

The federal agency has accepted the sBLA for Priority Review designation, with a target action date of September 15, 2024.

The extended label approval is based on full evidence from the XTEND-Kids study.

Data from the ongoing phase 1/2 CHORD trial was presented at the ASGCT annual conference.

The new data, published in The Lancet, showed that nirsevimab substantially reduced RSV hospitalizations.

The resubmission was announced in a first quarter, 2024 earnings news release from Lilly, which expects "regulatory action in the second half of 2024."

The rare genetic disease causes the body's immune system to not function properly.

A decision from the federal agency is expected in the fourth quarter of 2024.

With the approval comes the immediate availability of 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg doses for patients between 2 to 5 years of age.

This decision from the federal agency marks the first FDA approval of a systemic therapy to treat patients with pediatric LGG with BRAF rearrangements, including fusions.

The biosimilar to ustekinumab is approved for patients 6 years and up, and is expected to be marketed on or after February 21, 2025.

Abeona's pz-cel is up for indicated use to treat patients with recessive dystrophic epidermolysis bullosa.

The 5-in-1 vaccine candidate has the potential to reduce shots and simplify the immunization process.

Juanita Mora, MD, breaks down the FDA approval of benralizumab as an add-on maintenance therapy among patients with severe asthma aged 6 to 11 years.

The treatment is approved for adolescents aged 12 years and older.