OX124 is based on Orexo´s world-class drug delivery platform, amorphOX®, and is designed to reverse the effects of the most powerful synthetic opioids, such as fentanyl Synthetic opioids are behind 91 ...

PLAINSBORO, N.J., May 2, 2025 /PRNewswire/ -- Today, Novo Nordisk announced that the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) submission for an investigational ...

Axsome Therapeutics (AXSM) on Wednesday said it received formal pre–New Drug Application (NDA) meeting minutes from the U.S.

FDA has set a target action date of October 4, 2024sNDA supported by two Phase 1 safety studies1Aims at actinic keratosis (AK) field treatment with up to 3 tubesAn estimated 13 million treatments ...

Sanofi SNY announced that the FDA has accepted its regulatory filing seeking approval for its investigational BTK inhibitor tolebrutinib to treat non-relapsing secondary progressive multiple sclerosis ...

FibroBiologics submits IND application with US FDA to initiate clinical trials of CYPS317 in psoriasis patients: Houston Saturday, January 3, 2026, 11:00 Hrs [IST] FibroBiologics ...

SEATTLE--(BUSINESS WIRE)--Pluristyx, a leading provider of innovative, unmodified, and gene-edited induced pluripotent stem cell (iPSC) lines, submitted a Type II Drug Master File (DMF) to the U.S.

Establishment Labs ESTA recently announced that it has submitted its Motiva breast implants to the FDA for approval in ...