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

PTC Therapeutics' NDA resubmission of Translarna was based on data from Study 041 and the long-term STRIDE registry. No PDUFA action date was provided for regulators.

Prademagene zamikeracel (pz-cel) could be a new treatment for rare genetic disease recessive dystrophic epidermolysis bullosa (RDEB).

Qsymia’s manufacturer also released postmarketing data showing the oral therapy for weight loss was associated with reductions in 24-hour mean systolic blood pressure.

Gavreto used to treat metastatic RET fusion-positive non-small cell lung cancer and RET fusion-positive thyroid cancer.

This week’s approval expands Seldardsi indications to treat adults with Crohn’s disease and ulcerative colitis.

Zolbetuximab — now with the brand name Vyloy — is a monoclonal antibody to treat patients with advanced gastric and gastroesophageal cancers.