FDA Approves First At-Home Brain Stimulation Device For Depression

Swedish neurotech startup Flow Neuroscience has secured FDA approval for the first brain stimulation device for home use in ...
MassDevice

Neurolief gets FDA approval for at-home neuromod that treats depression

Neurolief announced today that the FDA granted approval for its Proliv Rx at-home neuromodulation therapy for treating ...
MedPage Today on MSN

FDA Approves At-Home Device for Treatment-Resistant Depression

The FDA approved a prescription at-home brain neuromodulation therapy as an adjunctive depression treatment for adults, maker ...
FiercePharma

With FDA approval, Roche's blood cancer bispecific Lunsumio goes subcutaneous

Three years after its initial FDA approval, Roche has made up for an early disadvantage with its blood cancer drug Lunsumio amid competition among CD20xCD3 bispecific antibodies. The FDA has approved ...
Boise State Public Radio

The FDA has approved an at-home HPV test. What you need to know

New federal guidance is expanding testing for cervical cancer with a self-collection method. Dr. Mara Gordon speaks to NPR about why this option might become popular for screening for HPV.
Wall Street Journal

Pill Version of Wegovy Is Approved for Use in the U.S.

U.S. regulators approved the first GLP-1 weight-loss pill—a tablet formulation of Novo Nordisk’s NOVO.B3.00%increase; green up pointing triangle Ozempic and Wegovy—ushering in a new era of the obesity ...
Medscape

FDA Expands Flibanserin Approval to Postmenopausal Women With Hypoactive Sexual Desire Disorder

Flibanserin (Addyi), the drug manufactured by Sprout Pharmaceuticals for the treatment of hypoactive sexual desire disorder (HSDD), received approval from the FDA for use in postmenopausal women up to ...
Psychiatry Advisor

FDA Clears At-Home Neuromodulation Device for Major Depressive Disorder

The FDA clears ProlivRx at-home neuromodulation for adjunctive major depressive disorder treatment in adults with inadequate antidepressant response.
ABC7

With FDA approval of Wegovy pill, new era of oral GLP-1 weight loss drugs begins

The US Food and Drug Administration on Monday approved a daily pill version of Novo Nordisk's weight-loss drug Wegovy, introducing a new option for how patients can take medicines in a class of drugs ...
Morningstar

FDA Approves Genentech’s Lunsumio VELO™ for Subcutaneous Use in Relapsed or Refractory Follicular Lymphoma

– Approval supported by data demonstrating compelling complete response rate in third-line or later follicular lymphoma, which typically becomes harder to treat after each relapse – Genentech, a ...
Business Wire

Establishment Labs Submits to FDA for Approval of Motiva Implants in Breast Reconstruction

NEW YORK--(BUSINESS WIRE)--Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company dedicated to improving women’s health and wellness, principally in breast aesthetics and ...
MedTech Dive

Stereotaxis wins FDA approval for robotically navigated ablation catheter

Stereotaxis’ CEO said the company has been “hampered clinically, commercially and strategically” by its prior dependence on a ...