Formulary Watch |

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.

Icotrokinra is a first-in-class targeted oral peptide that blocks interleukin (IL) 23 and its receptor, which plays a key role in the inflammatory response in plaque psoriasis.

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

Some vials in two lots of the antibiotic cefazolin are labeled as being penicillin G potassium, which if used could lead to suboptimal outcomes, adverse events, drug interactions and delayed recovery.

This new Shingrix vaccine presentation eliminates the need for reconstitution, simplifying the administration process for healthcare professionals.

Following in the footsteps of other pharmaceutical companies, Bristol Myers Squibb and Pfizer are offering Eliquis for cash-paying patients at a discount of 40% off the list price.

Leqselvi (deuruxolitinib) 8 mg tablets are approved for adults with severe alopecia areata, a disease that causes the immune system to attack hair follicles, leading to partial or complete hair loss on the scalp and body.

Kerendia was originally approved in July 2021 to reduce cardiovascular and kidney complications in patients with chronic kidney disease (CKD) associated with type 2 diabetes. This new approval extends its use to a broader patient population.

Orsini will be the specialty pharmacy partner for Ekterly.

According to Regeneron, the drug is a bispecific antibody that binds to B-cell maturation antigen (BCMA) on cancerous plasma cells and CD3 on T cells, directing the immune system to attack and destroy multiple myeloma cells.

Optum Rx officials said they now have eliminated reauthorization requirements for more than 140 chronic disease medications.

A separate Prime analysis, however, of year-over-year claims data for Wegovy and Zepbound only found an improvement in adherence in 2024, suggesting there is an evolving understanding of obesity treatment.

More than 50 insurers have pledged to streamline and simplify the prior authorization process through six new commitments.

The FDA had resolved the shortage of Wegovy in April, and telehealth providers were advised to stop selling compounded semaglutide products. Novo Nordisk said that Hims & Hers continues to offer these compounded drugs.

This approval marks the eighth disease indication for Dupixent as a new alternative for patients—many of whom are elderly and have limited treatment options.

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.

Wyost and Jubbonti are interchangeable with Xgeva/Prolia and are approved for all of the same indications in bone cancer and osteoporosis.

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

In an interview, James D. Chambers, Ph.D., from Tufts Medical Center, talks about the factors that are impacting the biosimilar market.

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.