Eusa hopes the approval will help cement its efforts in the U.S., where it has been trying to build a strong presence for several years.
EUSA Pharma announced Nov. 18 that it had received approval from FDA for its acute lymphoblastic leukemia (ALL) treatment Erwinaze (asparaginase Erwinia chrysanthemi), an alternative for pediatric patients who have developed a hypersensitivity to the normal course of therapy.
Most patients with the bone marrow cancer -- ALL affects about 6,000 people, both children and adults, annually – are...
While treatments for scleroderma are in development, none are approved for the condition that is associated with high morbidity and mortality. The European Medicines Agency says guidance on how to design development programs for the disorder is needed.
Madrigal Pharmaceuticals’ Rezdiffra is on track to become the first medicine approved in the EU for non-cirrhotic metabolic dysfunction-associated steatohepatitis after the European Medicines Agency recommended that it be granted conditional marketing authorization.
Highlights from Day Four of the BIO International Convention include policy concerns helping constrain dealmaking, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.
