The FDA has approved roflumilast (ZORYVE) foam 0.3% for once-daily treatment of plaque psoriasis in patients aged 12 and older, including hard-to-treat scalp and body areas..
The FDA has cleared IB-Stim as the first treatment specifically indicated for pediatric functional dyspepsia and related nausea, providing a noninvasive neuromodulation option for abdominal pain in patients aged 8 to 21 years.
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The new guidance is intended to “foster drug product development, ANDA submission and approval, and ultimately provide increased access to generic drugs."