December 19, 2024
The US Food and Drug Administration (FDA) has approved remestemcel-L (Ryoncil, Mesoblast Ltd), an allogeneic bone marrow‒derived mesenchymal stromal cell (MSC) therapy for steroid-refractory acute graft-vs-host […]
December 18, 2024
The US Food and Drug Administration (FDA) has approved ensartinib (Ensacove, Xcovery Holdings, Inc.) for the treatment of adults with ALK-positive locally advanced or metastatic non-small […]
December 17, 2024
The US Food and Drug Administration has approved crinecerfont (Crenessity) for use in combination with glucocorticoids in the treatment of adults and children aged 4 years […]
December 16, 2024
The US Food and Drug Administration (FDA) has approved tapinarof cream, 1% for the treatment of atopic dermatitis (AD) in adults and pediatric patients 2 years […]
December 16, 2024
The US Food and Drug Administration (FDA) has approved the immune checkpoint inhibitor cosibelimab (Unloxcyt; Checkpoint Therapeutics, Inc.) for the treatment of adults with metastatic or […]
December 15, 2024
The US Food and Drug Administration (FDA) has approved nemolizumab for moderate-to-severe atopic dermatitis inadequately controlled with topical therapies in patients aged 12 years and older, […]
December 13, 2024
Two treatments for children with attention-deficit hyperactivity disorder (ADHD) have been recommended by the European Medicines Agency (EMA) to receive marketing authorizations. Paxneury for ADHD Symptoms […]
December 13, 2024
The European Medicines Agency (EMA) has given a positive recommendation for Rytelo (imetelstat) for the treatment of adult patients with transfusion-dependent anemia due to very low-, […]
December 13, 2024
Europe’s Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorization for two drugs for preventing COVID-19: a monoclonal antibody called Kavigale (sipavibart) and […]