Articles tagged “fda-approvals”

10 articles found

Clinician and patient silhouettes beside a monthly medication schedule symbol, calm editorial illustration

mental-health fda-approvals treatment-access

FDA Approves Weltruza, a Once-Monthly Olanzapine Injection

Teva's Weltruza becomes the first once-monthly subcutaneous olanzapine injection for adults with schizophrenia, with no loading dose and no monitoring after shots.

October 11, 20265 min read

Pharmaceutical research campus with molecule structures, lab glassware and an abstract pain-relief symbol, warm editorial illustration

opioid-crisis fda-approvals clinical-research

Viatris to Buy Pacira for $1.65 Billion in Non-Opioid Pain Push

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.

October 10, 20264 min read

Editorial illustration of a nasal spray rescue medicine beside a first aid kit and protective network lines in warm muted tones

naloxone fda-approvals harm-reduction

Orexo Resubmits FDA Application for High-Dose Naloxone Nasal Powder

Orexo completed a resubmission of its new drug application for IZIPRY, a high-dose naloxone nasal powder, answering a 2024 FDA rejection letter.

September 30, 20265 min read

Medical device with neural stimulation symbols and brain wave patterns, warm editorial illustration

substance-use-disorder digital-health clinical-trials

FDA Grants Breakthrough Status to Device for Stimulant Use Disorder

NET Recovery's wearable neurostimulation device receives FDA Breakthrough Device Designation for stimulant addiction, where no drug or device is currently approved.

September 25, 20265 min read

Medical research laboratory with pill and medication symbols, nerve pathway visualization representing pain relief innovation

opioid-crisis fda-approvals clinical-research

FDA Approves Suzetrigine, First New Non-Opioid Pain Drug in Decades

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.

August 23, 20265 min read

Naloxone nasal spray device with emergency medical symbols, warm editorial illustration

harm-reduction naloxone fda-approvals

REZENOPY, Highest-Dose Naloxone Nasal Spray, Enters U.S. Market

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.

July 10, 20264 min read

FDA regulatory enforcement symbols with online pharmacy silhouettes and warning documentation, warm editorial illustration

fda-approvals telehealth psychedelics

FDA Sends Warning Letters to 14 Online Ketamine Sellers Over Unapproved Products

FDA cracks down on illegal online ketamine market with 14 warning letters to websites selling non-approved ketamine products for depression and addiction treatment.

July 8, 20265 min read

Auricular neurostimulation device on ear with medical technology symbols, warm editorial illustration

opioid-addiction medication-assisted-treatment fda-approvals

FDA Clears Drug Relief, a Neurostimulation Device to Ease Opioid Withdrawal Symptoms

DyAnsys Drug Relief receives FDA clearance as a non-narcotic auricular neurostimulation device designed to alleviate opioid withdrawal symptoms during detoxification.

July 5, 20267 min read

Editorial illustration showing pharmaceutical research symbols, FDA approval stamps, and psychedelic therapy concepts in warm muted tones

psychedelics fda-approvals clinical-trials

FDA Grants Quick Review for Three Psychedelic Drug Trials in Major Policy Shift

FDA awards priority review vouchers to Compass Pathways, Usona Institute, and Transcend Therapeutics for psilocybin and methylone therapies targeting treatment-resistant depression and PTSD.

April 24, 20267 min read

Modern medical device with gentle brain stimulation visualization, hopeful home setting, warm editorial illustration

mental-health treatment-access fda-approvals

FDA Approves First At-Home Brain Stimulation Device for Depression Treatment

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

April 18, 20268 min read

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