FDA Actions in Brief

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.