10 more PDUFA dates in January following year’s first FDA approval 

After granting the first approval of 2024 on Friday, FDA is looking ahead to at least 10 more target action dates in January. Among the most high-profile is a BLA seeking approval of what could become the first CLDN18.2 inhibitor to reach the market.

Ligand Pharmaceuticals Inc. (NASDAQ:LGND) said that Zelsuvmi berdazimer topical gel would be available starting in 2H24 following FDA’s approval of the nitric oxide releasing agent to treat the skin infection molluscum contagiosum. Zelsuvmi will compete with Ycanth cantharidin, a therapy from Verrica Pharmaceuticals Inc. (NASDAQ:VRCA) that FDA approved in July. The key difference between the two products is that Zelsuvmi can be applied by the patient or caregiver in their home, whereas Ycanth must be applied by a provider. ...