FDA Grants BMS’ Opdivo Priority Review For Liver Cancer May 30, 2017 The submission was based on data from a Phase I/II clinical study. Read More
FDA Grants First-Line Approval to Zykadia in ALK-Positive NSCLC May 30, 2017 The trial’s estimated median PFS of 16.6 months with Zykadia. Read More
FDA Committee Endorses Treatments for Breast Cancer, Sickle Cell Disease May 30, 2017 The committee recommended neratinib for approva in a voted 12 to 4 vote. Read More
NICE Gives Final Guidance on Cimzia and Cosentyx May 29, 2017 The recommendation is contingent on keeping the cost low through patient access schemes. Read More
Biogen’s Fampyra Awarded Standard Marketing Authorization in EU May 29, 2017 The full clearance was based on the results of a Phase 3 clinical study. Read More
CHMP Recommends 11 Medicines for Approval, Including Four Biosimilars May 29, 2017 The Spherox cell therapy was developed by CO.DON to repair cartilage defects in the knee. Read More
FDA Committee Recommends Hospira’s Epogen/Procrit Biosimilar for Approval May 25, 2017 An FDA advisory committee endorsed Hospira’s biosimilar version of Epogen and Procrit, used to stimulate the production of red blood cells. Read More
Sanofi and Regeneron Receive FDA Approval for Kevzara in Rheumatoid Arthritis May 25, 2017 Kevzara is an antibody that binds to the interleukin-6 receptor. Read More
FDA Committee Endorses Treatments for Breast Cancer, Sickle Cell Disease May 24, 2017 An FDA advisory committee recommended Wednesday that the agency approve two NDAs, one in breast cancer and one in sickle cell disease. Read More
FDA Expands Actemra Indication to Treat Giant Cell Arteritis May 24, 2017 Clinical results showed patients achieving sustained remission from week 12 through week 52. Read More
Keytruda Receives First Oncology Approval Based on Tumor Genetics, not Organ Site May 23, 2017 In a first, the FDA granted an indication to a cancer immunotherapy based on a tumor’s genetic makeup, regardless of disease site or tissue. Read More
GlycoMimetics’ Leukemia Drug Wins FDA Breakthrough Therapy Designation May 23, 2017 The drug is an E-selectin antagonist currently being evaluated in the Phase II clinical trial. Read More