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

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

Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have ...

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

The FDA cleared an investigational new drug application to advance NOV05 in a phase 2 clinical trial in noninfectious ...

The MarketWatch News Department was not involved in the creation of this content.-- Centanafadine is an investigational compound for the treatment of ADHD in children, adolescents ...

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 FDA granted breakthrough therapy designation to bezuclastinib plus Sutent for patients with gastrointestinal stromal ...

FDA grants Priority Review and assigns a PDUFA goal date of July 17, 2026MINNEAPOLIS, (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: ...

Phase 1b clinical site start-up and regulatory activities in Australia underway to support the global registrational program - ...

Breakthrough sleep apnea medication AD109 shows promising results in phase 3 trials, potentially helping 30 million Americans with the condition.

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 ...