FDA Pipeline preview, September 2009 (cethromycin, pegloticase, guanfacine, denosumab, apaziquone, TZP-102, beclomethasone 17,21-dipropionate)

Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.

An additional seven lots of Treprostinil are affected on top of last month’s recall of one lot.

Entyvio as an injection and subcutaneous formulations is approved to treat both Crohn’s and ulcerative colitis.

Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.

Researchers were unable to find a significant benefit for patients for the majority of cancer medications given accelerated FDA approval.

The vaccine combines the antigenic components of its two meningococcal vaccines: Bexsero and Menveo. The action date is Feb. 14, 2025.