Verrica’s Molluscum Product Set Back By FDA Usage Questions
Verrica got a complete response rather than approval for its drug/device combo for molluscum, but says the FDA only needs additional information on product changes for safe usage by clinicians.
You may also be interested in...
Verrica’s Ycanth, a drug-device combination product containing a formulation of cantharidin, is approved by the FDA as the first treatment for molluscum, after three complete response letters.
Headquartered in both China and US, the new firm will help partners bring drugs to China and other Asian markets. Novavax licenses COVID-19 vaccine in Japan to Takeda, following previous week’s deal for the vaccine in India.
The year began with an unusually low number of CRLs, but a recent burst of non-approval actions suggests a COVID-19 effect.