Johnson & Johnson (NYSE: JNJ) today announced the nipocalimab Biologics License Application (BLA) received Priority Review designation from the U.S Food and Drug Administration (FDA) for the treatment ...

Biologics License Application acceptance supported by results from the Phase 3 Vivacity-MG3 study Results demonstrate sustained disease control over 24 weeks in a broad ...

The application is supported by data from the randomized, double-blind, placebo-controlled phase 3 Vivacity-MG3 study.

Patients with generalized myasthenia gravis experienced durable improvements across measures of efficacy and regardless of the time since they were diagnosed.

In 2024, the field of myasthenia gravis (MG) saw many developments from clinical trials of new treatments, including ...

Johnson & Johnson has won Food and Drug Administration priority review for its application seeking approval of nipocalimab in certain patients with generalized myasthenia gravis.

The first effective treatment for myasthenia gravis was acetylcholinesterase (AChE) inhibitors, which were introduced in 1934. These medications helped improve the mortality rate to 32% within 6 ...

Johnson & Johnson (NYSE:JNJ) has received Priority Review designation from the FDA for the Biologics License Application for ...

Fatigue and difficulties chewing and swallowing can compromise nutrition in patients with MG. Difficulty chewing results from jaw fatigue as the meal progresses. 2,5 Swallowing is affected due to ...