The candidates must make sure that they enter valid details associated with the NDA eligibility criteria in the application form to avoid cancellation of the candidature. Here are the key ...

The FDA has set a PDUFA target action date of October 23, 2025, for the low-dose atropine formulation.

The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for SYD-101 (atropine sulfate) to slow the progression of ...

The purpose of this meeting is to review the XRx-026 program and its readiness for submission of a New Drug Application (“NDA”) to gain marketing approval for XORLO ™ in the US using the FDA ...