FDA

The FDA has accepted the new drug application for the antipsychotic Bysanti and set a goal date for February 21, 2026.

If approved, Wegovy would be the first oral GLP-1 drug to treat obesity.

Adult and pediatric generalized myasthenia gravis patients have a new, longer acting option for treatment called Imaavy.

The complete response letter did not identify any issues with the safety or efficacy of Eylea HD, Regeneron officials said.

Chronic spontaneous urticaria is chronic inflammatory skin disease driven in part by type 2 inflammation, which causes sudden and debilitating hives and recurring itch.

If approved, Eylea would be the first treatment for RVO with 8-week dosing. The FDA target action date is Aug. 19, 2025.

Jobevne is the fifth Avastin biosimilar, which are recombinant humanized monoclonal antibodies used to treat several different types of cancer.

The FDA has set a goal date of Aug. 27, 2025. If approved, the therapy would be branded as Lytenava and be the first ophthalmic formulation of bevacizumab.

Uplizna is the first approved treatment for immunoglobulin G4-related disease (IgG4-RD), a chronic inflammatory condition that can affect multiple organs. It has a price of $140,248.50 per dose.

Vanrafia reduces proteinuria in adults with primary immunoglobulin A nephropathy (IgAN). It has a wholesale acquisition cost of $162,500 annually.

The fourth pair of denosumab biosimilars, Conexxence and Bomyntra, are expected to launch in the United States in mid 2025, as a result of a global settlement with Amgen, according to a company news release.

Vykat XR will be available in April to treat the intense hunger that is a hallmark of the rare genetic disease Prader-Willi syndrome. The price is based on a patient’s weight, and the average patient in the clinical trials would have had an average annual cost of $466,200 for the first year.

Blujepa is the first in a new class of oral antibiotics in 30 years. It is expected to launch in the second half of 2025 in the United States.

Neuroendocrine tumors that start in the pancreas tend to be more aggressive and have a poor prognosis.

This expanded indication for Amvuttra makes it the first and only FDA-approved treatment for transthyretin amyloidosis with cardiomyopathy (ATTR-CM) and the polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR-PN) in adults.

Tremfya is also approved to treat patients with plaque psoriasis, active psoriatic arthritis and ulcerative colitis and is available as both a subcutaneous and intravenous induction option.

This is the third approval for Fabhalta (iptacopan), which was discovered and developed by Novartis.

Regulators are expected to make a decision in the third quarter of 2025 on Kerendia to treat patients with heart failure with a left ventricular ejection fraction (LVEF) of ≥40%.

Two companies have received approved for a generic of the 2.5 mg tablet of anticoagulant rivaroxaban, which is used to reduce the risk of stroke and deep vein thrombosis.

Celltrion’s Omlyclo is interchangeable with Xolair to treat the same conditions: asthma, chronic rhinosinusitis, food allergy and chronic spontaneous urticaria.

Neffy 1 mg is now approved by the FDA to treat pediatric patients who weigh 33 to 65 lbs. Neffy was first FDA-approved as a 2 mg dose in August 2024 for the emergency treatment of anaphylaxis in children and adults weighing at least 66 lbs.

Esophageal squamous cell carcinoma accounts for approximately 90% of all esophageal cancer cases. Projections estimate that by 2040, there will be approximately 957,000 new cases of esophageal cancer worldwide, marking a nearly 60% increase from 2020, according to BeiGene.

The FDA has accepted Amneal’s biologics licensing application for two biosimilars referencing Prolia and Xgeva.

The FDA had approved Otulfi in September 2024 to treat Crohn’s disease, ulcerative colitis, psoriasis and active psoriatic arthritis. Information on pricing is not yet available.

This once-daily topical treatment is the latest phosphodiesterase-4 (PDE4) inhibitor designed for mild to moderate atopic dermatitis (AD) in children aged 2 to 5 years. The PDUFA target action date of October 13, 2025, is set for its decision on the application.

The FDA has accepted the biologics licensing application (BLA) resubmission for odronextamab, a potential treatment for relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma.

Merilog is expected to be available in July 2025, and Sanofi will provide Merilog to patients for $35 or less for a 30-day supply.

Lenacapavir is a twice-yearly injectable medication designed to be used as pre-exposure prophylaxis (PrEP). The FDA is giving this drug a priority review and expects to make a decision by June 19, 2025, according to a release.

So far, five biosimilars that reference Eylea 2 mg have been approved by the FDA. Alvotech/Teva expect to regulatory approval for its biosimilar to be completed in the fourth quarter of 2025.

Samsung Bioepis’ biosimilars Ospomyv and Xbryk have been approved to be interchangeable with Prolia/Xgeva treat osteoporosis and multiple myeloma/bone metastases from solid tumors.