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

Eton Pharmaceuticals' ET-600 met bioequivalence standards in a study, with an FDA filing planned for April 2025 and a ...

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

CING READ THE FULL CING RESEARCH REPORT Since the report of third quarter results, Cingulate, Inc. (NASDAQ:CING) has executed ...

In a regulatory filing, Cytokinetics (CYTK) disclosed that at upcoming investor conferences, the company will be providing, and is hereby ...

Corcept Therapeutics (CORT) announced that the FDA filed its New Drug Application (NDA) submission for its proprietary, selective cortisol ...

today announced that it has received formal pre-New Drug Application (NDA) meeting minutes from the U.S. Food and Drug Administration (FDA) supporting a supplemental NDA (sNDA) submission for AXS ...

has accepted its New Drug Application (NDA) for SYD-101 and has assigned a Prescription Drug User Fee Act (PDUFA) target action date of October 23, 2025. If approved, SYD-101 would be the first ...

Type C Meeting Requested to Accelerate XRx-026 for Gout to NDA ● CALGARY, Alberta, Feb. 24, 2025 (GLOBE NEWSWIRE) -- XORTX ...

Treatments for dry eye disease, neuroendocrine tumors, chronic spontaneous urticaria, Barth syndrome, and migraine are under review.

Antengene’s Xpovio NDA has gained approval from the Indonesia National Agency of Drug and Food Control for three indications.

A Prescription Drug User Fee Act target date of December 30, 2025 has been set for the application. The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA ...