The Prescription Drug User Fee Act target action date for the NDA is scheduled for 24 July 2026.

FDA assigns Prescription Drug User Fee Act (PDUFA) target date of June 29, 2026Ended 2025 with unaudited cash position of $41 ...

New sublingual delivery system designed to enhance bioavailability and avoid gastric side effects many patients experience ...

Silo Pharma, Inc. has announced the filing of a patent application for its neurology drug, SPC-14, which is an intranasal treatment for Alzheimer's disease. This compound, licensed from Columbia ...

Unicycive Therapeutics (UNCY) announced on Thursday that the U.S. Food and Drug Administration (FDA) has accepted its ...

Achieve Life Sciences, Inc. has submitted a New Drug Application (NDA) to the U.S. FDA for cytisinicline, which, if approved, would be the first new pharmacotherapy for nicotine dependence in 20 years ...

The U.S. Food and Drug Administration (FDA) has accepted a new drug application for gedatolisib in hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), PIK3CA ...

The US Food and Drug Administration (FDA) has cleared Novaliq’s Investigational New Drug (IND) application for NOV05, enabling the initiation of the EYETAC phase II clinical trial ( NCT07285070) in ...

Investing.com -- Unicycive Therapeutics (NASDAQ:UNCY) stock rose 3% Thursday morning after the company announced that the U.S ...

FDA staffers and outside experts worry the program runs afoul of legal, ethical and scientific standards used to review new ...