March 26th 2025
The commission’s approval makes durvalumab the first and only immunotherapy for LS-SCLC in the EU.
Sandoz’s Rituximab and Etanercept Biosimilars Recommended for European Approval
April 24th 2017Sandoz, a Novartis division, announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinions recommending the approval of its biosimilars rituximab and etanercept in Europe, for the same indications as the respective reference medicines.
Deficiencies in Manufacturing Derail CDER Approvals in 2016
January 5th 2017FDA’s Center for Drug Evaluation and Research (CDER) approved 22 new molecular entities (NMEs) in 2016, according to a January 4, 2016 release from the agency. Of the 22 NMEs, 12 were large-molecule therapeutics. Of CDER’s 45 novel drug approvals in 2015, 17 were considered large-molecule therapeutics (larger than 900 Daltons).In 2016, 11 of the 12 large-molecule drugs that were approved were biologics. This includes seven monoclonal antibodies (mAbs), one hormone, and three DNA-derived medications. The remaining large-molecule medication was a diagnostic agent.