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President Obama’s nomination of Robert Califf to lead the FDA is drawing praise from those in industry and academia who see him as an outstanding choice and a strong leader deeply respected by the scientific community. Read More
The FDA issued a warning letter to Coram Healthcare over its Crownpoint, Ind., facility for serious deficiencies in producing sterile drug products. Read More
The FDA has clarified prescribing information for antipsychotic drug clozapine, explaining how to monitor and manage treatment of patients with neutropenia. Read More
California-based biopharmaceutical companies Amgen and Xencor entered into a research and license agreement that could be worth as much as $1.7 billion to develop and commercialize therapeutics focused on cancer immunotherapy and inflammation. Read More
Amgen is acquiring Dutch biotechnology company Dezima Pharma for $300 million plus up to $1.25 billion in milestone payments, the companies announced Wednesday. Read More
The FDA awarded Bristol-Myers Squibb’s Opdivo a breakthrough therapy designation for metastatic renal cell carcinoma, adding another potential indication to the growing list for the PD-1 inhibitor. Read More