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Addyi, the pill for premenopausal women with hypoactive sexual desire disorder, received FDA approval last month despite dissent from some reviewers that marginal clinical benefits did not outweigh the risks, an FDA summary said. Read More
CDER Director Janet Woodcock came under fire Thursday from senators demanding to know why the FDA is years behind Europe and Canada in establishing a workable program for biosimilars. Read More
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