Company’s patented desmopressin oral solution successfully passed pivotal bioequivalence study -- Company expects to submit ...
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 ...
In a regulatory filing, Cytokinetics (CYTK) disclosed that at upcoming investor conferences, the company will be providing, and is hereby ...
Discover how outsourcing regulatory submission content development improves efficiency and ensures compliance.
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 ...
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 ...
Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment of nicotine dependence ...
Treatments for dry eye disease, neuroendocrine tumors, chronic spontaneous urticaria, Barth syndrome, and migraine are under review.
Q4 2024 Earnings Call Transcript March 13, 2025 Cellectar Biosciences, Inc. beats earnings expectations. Reported EPS is ...
The investment of over $6 million will expand LGM Pharma’s Rosenberg, Texas manufacturing facility as part of its Phase I ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results