The approval marks the second international approval for rozanolixizumab (Rystiggo; UCB Pharma) for generalized myasthenia gravis (gMG), behind the February EU approval of 2 self-administration ...

The primary endpoint of the trial is safety and tolerability, and key secondary endpoints include myasthenia gravis activities of daily living scale (MG-ADL) and quantitative myasthenia gravis (QMG) ...

The FDA has approved Johnson & Johnson’s nipocalimab (Imaavy) for adults and paediatric patients 12 years of age and older with generalized myasthenia gravis (gMG) and anti-acetylcholine ...

May 2, 2025 -- The FDA has approved a new treatment for generalized myasthenia gravis (gMG), a disease that causes severe muscle weakness, faster muscle fatigue, and difficulty in speaking and ...

The primary endpoint of the trial is safety and tolerability, and key secondary endpoints include Myasthenia Gravis Activities of Daily Living Scale (MG-ADL) and Quantitative Myasthenia Gravis ...

“FDA’s approval of IMAAVYTM (nipocalimab-aahu) is an important step in expanding treatment options for people living with myasthenia gravis,” said Donald S. Wood, PhD, President and ...

The FDA has approved Alexion's Soliris for use in patients with treatment resistant generalised Myasthenia gravis (gMG), making it the first new therapy for the condition in 60 years.

Sanofi is still plugging away with its oral BTK inhibitor tolebrutinib in multiple sclerosis, but has decided to abandon efforts to develop the drug for neuromuscular disorder myasthenia gravis.

said the company’s work around the launch of the prefilled syringe reflects discussions with generalized myasthenia gravis (gMG) patients. “We listened to the voices of patients in the gMG ...

The FDA approved nipocalimab (Imaavy) injection to treat adults and children ages 12 and older with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) or anti-muscle ...

The FDA has approved the J&J drug, known in development as nipocalimab, as a treatment for generalized myasthenia gravis (gMG). The regulatory decision announced Wednesday could be the first of ...

EXCLUSIVE: Oscar winners and husband-and-wife cinema royalty Javier Bardem (No Country for Old Men) and Penélope Cruz (Vicky Cristina Barcelona) are set to reunite on screen in psychological ...