Less than two years after the FDA cleared Theranica Bio-Electronics’ Nerivio neuromodulation armband as an acute migraine treatment in 2019, the company successfully lobbied the agency to expand its indication from adults only to all patients aged 12 and older with episodic or chronic migraine.

Salarius Pharmaceuticals has paused enrollment on a phase 1/2 trial of its lead candidate following the death of a patient.

A patient with beta thalassemia or sickle cell disease—genetic disorders that affect the blood protein hemoglobin in red blood cells—currently has only two options for treatment. They can medicate the diseases’ many lifelong symptoms, or they can undergo a curative bone marrow transplant.

Roche has taken the scissors to its clinical development pipeline, snipping off phase 2 studies of potential treatments for hepatitis B virus and geographic atrophy in the quarterly cull of its investigational assets.

As special purpose acquisition company (SPAC) deals in biotech make a slow comeback, another merger has been penned, this time between Swiss biotech Oculis and European Biotech Acquisition Corp (EBAC).

Arrivo Bioventures’ depression med failed to improve symptoms in a phase 2 study, but the company is spinning the results as a positive outcome by pointing to promise specifically in women.

Monday marked the first day that some hearing aids may be sold over the counter, without requiring any prescriptions, hearing tests or fitting appointments, thanks to a recently finalized—and long-awaited—ruling from the FDA.

The long and winding road Biogen’s tofersen has taken to FDA approval just got longer, with the agency delaying its decision on the amyotrophic lateral sclerosis (ALS) drug until April.

Sage Therapeutics and Biogen have shared a closer look at phase 3 data on zuranolone in postpartum depression (PPD), presenting secondary endpoint results from SKYLARK while racing to wrap up a filing for FDA approval.

Milestone Pharmaceuticals’ rescue mission has delivered a pivotal primary endpoint hit. Thirty months after failing its first phase 3, the nasal spray treatment for abnormal heart rhythm has beaten placebo in a second study, putting Milestone on track to file for FDA approval around the middle of next year.