Business · 15/07/2024Updated: 10/17/2026 · 1 min read
Takeda Pharmaceuticals U.S.A., Inc. Withdraws New Drug Application for EXKIVITY
Summary
Takeda Pharmaceuticals U.S.A., Inc. has voluntarily requested the FDA to withdraw approval of its new drug application for EXKIVITY (mobocertinib succinate) capsule, equivalent to 40 milligrams base, due to a lack of opportunity for a hearing.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →