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

Company’s patented desmopressin oral solution successfully passed pivotal bioequivalence study -- Company expects to submit New Drug ...

Aspire Biopharma Holdings, Inc. (NASDAQ:ASBP) (”Aspire” or the “Company”), a developer of a multi-faceted patent-pending drug delivery technology, today provided an update on its two patent ...

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

The investment of over $6 million will expand LGM Pharma’s Rosenberg, Texas manufacturing facility as part of its Phase I ...

Discover how outsourcing regulatory submission content development improves efficiency and ensures compliance.

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

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

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 ...

Discover UroGen Pharma’s promising 2024 earnings call insights, with FDA progress on UGN-102 targeting $1B potential, robust pipeline updates & ...