ACHV READ THE FULL ACHV RESEARCH REPORT Achieve Life Sciences, Inc. (NASDAQ:ACHV) reported 2024 results sharing progress with ...

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 ...

The FDA has accepted under Priority Review the NDA for lenacapavir for the prevention of HIV as pre-exposure prophylaxis.

The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for relacorilant to treat patients with Cushing syndrome (hypercortisolism).

Supplemental New Drug Application (sNDA) submission anticipated in 3Q 2025NEW YORK, March 03, 2025 (GLOBE NEWSWIRE) -- Axsome ...