FDA, stop sign

The U.S. Food and Drug Administration issued a Complete Response Letter to UCB regarding the Belgium-based company’s Biologics License Application for bimekizumab for adults with moderate to severe plaque psoriasis.

Two biologic therapeutic candidates met their primary endpoints in separate Phase III trials: AstraZeneca’s Ultomiris and Argenx’s Vyvgart.

AstraZeneca’s Alexion received a supplemental New Drug Application approval for Ultomiris (ravulizumab-cwvz) from the U.S. Food and Drug Administration to treat adults with generalized myasthenia gravis (gMG).

Global immunology firm Argenx shared positive topline results from the company’s ongoing study on the use of efgartigimod for generalized myasthenia gravis (gMG). 

Belgium-based UCB hit the mark in the company’s Phase III clinical trial assessing zilucoplan as a potential treatment for adults with generalized myasthenia gravis, a rare autoimmune disease. Vanda Pharmaceuticals’ late-stage study of tradipitant as a treatment for the symptoms of gastroparesis, a digestive disorder, failed to meet the trial’s primary endpoint.

The U.S. Food and Drug Administration approved Vyvgart (efgartigimod alfa-fcab) for the treatment of generalized myasthenia gravis (gMG) in adult patients positive for anti-acetylcholine receptor (AChR) antibody.

Digital-native agency closerlook won a bronze Pharma Lion for a docuseries developed with global immunology company argenx that depicts the experiences of people living with myasthenia gravis (MG), a rare and chronic neuromuscular autoimmune disease. The award win for “A Mystery to Me” was announced at the Cannes Lions International Festival of Creativity in France.

Boston-based Alexion Pharmaceuticals announced positive topline data from the company’s Phase III trial of Ultomiris (ravulizumab-cwvz) in adults with generalized myasthenia gravis.

The U.S. Food and Drug Administration placed a clinical hold on Larimar Therapeutics’ lead Friedreich’s ataxia (FA) asset, CTI-1601, after the company reported deaths in the highest dose levels of a nonhuman primate toxicology study.

Biogen and Capsigen forged a strategic collaboration to engineer novel adeno-associated virus (AAV) capsids that have the potential to become transformative gene therapies that treat underlying genetic causes of various central nervous system and neuromuscular disorders.