FDA Actions in Brief (December 2006)

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.