Pratteln, Switzerland – Santhera Pharmaceuticals (SIX: SANN) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending an extension to the marketing authorization for AGAMREE® (vamorolone) to include the treatment of patients with Duchenne muscular dystrophy (DMD)...

HOUSTON, Texas — Cellenkos®, Inc., a clinical-stage biotechnology company, developing allogeneic, tissue-targeted regulatory T cell (Treg) therapies, today announced the receipt of U.S. Food and Drug Administration (FDA) clearance to initiate CK0801 Phase 2 clinical trial, for the treatment of aplastic anemia. Aplastic anemia, a rare and life-threatening blood disorder, continues to...

BERKELEY HEIGHTS, N.J. — Secura Bio, Inc., an integrated pharmaceutical company maximizing commercial outcomes for oncology medicines, today announced the publication in the Journal of Clinical Oncology of the Phase 2 PRIMO data indicating that duvelisib, an oral dual inhibitor of PI3K-delta and PI3K-gamma, demonstrated significant clinical activity and tolerability in patients...