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Articles tagged with “505-b-2-pathway”

Tradipitant FDA Approval: Motion Sickness Drug Mechanism

Review the FDA approval of tradipitant for motion sickness. Explore the pharmacology of this NK-1 receptor antagonist and its 505(b)(2) regulatory pathway.

35 min read

5/15/2026

tradipitant motion sickness fda approval nk-1 antagonist 505(b)(2) pathway antiemetics substance p pharmacology

CTx-1301 Dexmethylphenidate: FDA Review & ADHD Clinical Data

Explore the clinical data and 505(b)(2) FDA regulatory pathway for CTx-1301 (dexmethylphenidate), a novel once-daily stimulant candidate for ADHD treatment.

40 min read

5/14/2026

ctx-1301 dexmethylphenidate adhd medication 505(b)(2) pathway pdufa stimulant therapy precision timed release fda approval