11 articles found
The FDA accepted Orexo's resubmitted application for IZIPRY, a high-dose naloxone nasal powder, and set a March 29, 2027 target date for a decision.
Teva's Weltruza becomes the first once-monthly subcutaneous olanzapine injection for adults with schizophrenia, with no loading dose and no monitoring after shots.
Viatris agreed to pay $36.50 a share for Pacira BioSciences, adding the non-opioid pain drugs Exparel and Zilretta as opioid-sparing alternatives gain ground.
Orexo completed a resubmission of its new drug application for IZIPRY, a high-dose naloxone nasal powder, answering a 2024 FDA rejection letter.
NET Recovery's wearable neurostimulation device receives FDA Breakthrough Device Designation for stimulant addiction, where no drug or device is currently approved.
Suzetrigine (Journavx) becomes the first novel non-opioid pain medication approved by FDA in over 20 years, offering surgery patients effective pain relief with significantly lower opioid use.
Scienture Holdings begins shipping REZENOPY, a 10mg naloxone nasal spray—the highest FDA-approved dose—bringing a new overdose reversal option as fentanyl deaths decline nationwide.
FDA cracks down on illegal online ketamine market with 14 warning letters to websites selling non-approved ketamine products for depression and addiction treatment.
DyAnsys Drug Relief receives FDA clearance as a non-narcotic auricular neurostimulation device designed to alleviate opioid withdrawal symptoms during detoxification.
FDA awards priority review vouchers to Compass Pathways, Usona Institute, and Transcend Therapeutics for psilocybin and methylone therapies targeting treatment-resistant depression and PTSD.
Flow Neuroscience's transcranial direct current stimulation device becomes first prescription brain stimulation therapy available for home use, offering new option for treatment-resistant depression