-- New data suggest positive impact on clinical burden and sustained long-term clinical benefit for adult patients with anti-acetylcholine receptor (AChR) antibody-positive refractory generalized ...

New York, March 10, 2025 (GLOBE NEWSWIRE) -- The Muscular Dystrophy Association (MDA) welcomes the U.S. Food and Drug Administration (FDA) approval of the expanded indication of Alexion/AstraZeneca’s ...

The European Union has recommended for marketing authorization of AstraZeneca Plc's (NASDAQ: AZN) Soliris (eculizumab) for expanded use in refractory generalized myasthenia gravis (gMG) in children ...

We were unable to process your request. Please try again later. If you continue to have this issue please contact [email protected]. The expanded application makes this the first available ...

The FDA based its approval of the extended indication for Soliris on comprehensive clinical data from the Phase 3, randomized, double-blind, placebo-controlled, multicenter REGAIN study (ECU-MG-301).

SAN FRANCISCO—Alexion’s rollout of Soliris in generalized myasthenia gravis (MG) won’t be just any launch for the rare-disease product. The company thinks it can make the kickoff its best ever. “We ...

Amgen has reported positive phase 3 results with its biosimilar version of AstraZeneca/Alexion's blockbuster rare disease drug Soliris, setting up a regulatory filing with the FDA. The biotech has ...

Please provide your email address to receive an email when new articles are posted on . The U.S. Food and Drug Administration has granted orphan drug designation for Alexion Pharmaceuticals' Soliris ...

Alexion has submitted a marketing application to the Food and Drug Administration (FDA) to extend the indication for Soliris (eculizumab) to be a treatment for patients with refractory generalized ...

At the very beginning of 2018, Alexion figured its new Soliris approval in generalized myasthenia gravis (gMG) could deliver its lead drug's best launch. Now, as its third-quarter numbers show, that ...