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 FDA has accepted Otsuka’s New Drug Application for centanafadine, a first-in-class norepinephrine, dopamine and serotonin reuptake inhibitor (NDSRI) for the treatment of attention-deficit ...

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

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 ...

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

The FDA has accepted an investigational new drug application from a global biotechnology company for its investigational, ...

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

FDA grants AXS-05 Priority Review designation and sets PDUFA action goal date of April 30, 2026 NEW YORK, Dec. 31, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a ...

MALMÖ, SE / ACCESS Newswire / November 15, 2025 / Ascelia Pharma AB (publ) (ticker: ACE), a biotech focused on improving the life of people living with rare cancer conditions, today announced that the ...

The Food and Drug Administration commissioner's effort to drastically shorten the review of drugs favored by President Donald ...

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 ...