Shares of Milestone Pharmaceuticals Inc. (MIST) traded 60% lower on Friday after the Food and Drug Administration (FDA) did ...

CRL focused on CMC; no clinical issues relating to etripamil raised$69.7M in cash, cash equivalents and short-term investments as of December 31, ...

ACHV READ THE FULL ACHV RESEARCH REPORT Achieve Life Sciences, Inc. (NASDAQ:ACHV) reported 2024 results sharing progress with the new drug application (NDA) for cytisinicline and narrowing its ...

In 2023, the FDA rejected a small pharmaceutical company's new drug application (NDA ... Whether advocating CMC strategy, directing CMC operations, or developing CMC submission content that ...

New leadership appointments, including Dr. Kristen Slaoui and Nancy Phelan to the Board and Mark Oki as CFO, are expected to support the NDA submission and commercialization efforts. Achieve also ...

As we move down the home stretch towards the FDA submission, Cingulate has a pre-new drug application (NDA) meeting scheduled for early April and anticipates filing its NDA with the agency by mid ...

“We are pleased with the pre-NDA meeting feedback we received from the FDA, which confirmed the studies and data to be presented in our planned sNDA submission of AXS-05 for the treatment of ...