FDA

Brinsupri is the first approved therapy to address the underlying inflammatory process of non-cystic fibrosis bronchiectasis (NCFB).

Teva's Ajovy gains FDA approval for pediatric migraine prevention, offering hope for children aged 6-17 with this debilitating condition.

Modeyso is the first drug to treat patients with diffuse midline glioma with an H3 K27M mutation, an ultra-rare and aggressive brain tumor.

The FDA has approved VIZZ, a once-daily, preservative-free eye drop that improves near vision in adults with presbyopia for up to 10 hours.

Sarepta continues to work with regulators to complete the safety label update for Elevidys, and they are discussing an approach for risk mitigation for non-ambulatory patients.

Last week, an FDA advisory committee against the risk-benefit profile of Blenrep in combination with other therapies. Regulators and reviewers were concerned about the ocular side effects and dosing and tolerability. The new action date is Oct. 23, 2025.

Sarepta officials said the temporary halt in shipments was done to maintain a productive working relationship with regulators while they address a safety labeling update about the risk of acute liver disease related to Elevidys.

Elevidys is a gene therapy approved to treat Duchenne muscular dystrophy. Last month, Sarapta halted sales of the therapy for non-ambulatory patients.

Orsini will be the specialty pharmacy partner for Ekterly.

This is the first FDA-approved CD19- and CD20-targeted immunotherapy combination for adult patients with follicular lymphoma (FL) and the second indication for Monjuvi.

CSL Behring’s Andembry is now approved as a subcutaneous, self-injection for hereditary angioedema (HAE) patients ages 12 and older and will be available by the end of June 2025.

Aldeyra has resubmitted its new drug application for reproxalap, an investigational dry eye treatment, which contained new data from an additional FDA-requested trial.

A second patient with Duchenne muscular dystrophy has died from acute liver failure after receiving the gene therapy Elevidys.

The FDA has accepted a New Drug Application for zoliflodacin, a first-in-class oral antibiotic for treating uncomplicated gonorrhea, offering a potential new option amid rising antibiotic resistance.

Ibtrozi had a 90% response rate in treatment naïve adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer, according to the results of a news release.

Enflonsia is the first FDA-approved respiratory syncytial virus (RSV) preventative for infants, regardless of weight, according to the news release.

Sibeprenlimab would be offered in a prefilled syringe for subcutaneous injection. The PDUFA target action date is Nov. 28, 2025.

Nucula’s new indication is as an add-on therapy for patients with COPD who also have an elevated blood eosinophil count.

Susvimo is also approved to treat diabetic macular edema and age-related macular degeneration, and the medication, ranibizumab, is delivered through an ocular implant that is refilled every nine months.

Bayer’s Jivi is a factor VIII replacement therapy that has been engineered with a compound that allows for less frequent dosing. It is now indicated for patients 7 years of age and older.

Zynyz is now FDA-approved as the first and only approved first line treatment for advanced squamous cell carcinoma of the anal canal.

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.