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A new White House report urges an expanded accelerated approval programs and limited approvals to increase the number of innovativ...[ Price : $8.95]
Biogen Idec and Swedish Orphan Biovitrum say they plan to submit a BLA early next year for their investigational blood clotting fa...[ Price : $8.95]
CDRH staffers Thomas Gross and Jay Crowley tout the benefits of the agencys proposed unique device identifier system.[ Price : $8.95]
FDA accepts for review a GlaxoSmithKline and Theravance NDA for their once-daily investigational medicine Relvar for treating pati...[ Price : $8.95]
Forest Laboratories and Pierre Fabre Laboratories submit an NDA to FDA for levomilnacipran to treat major depressive disorder.[ Price : $8.95]
A Public Citizen report update finds that states are increasingly settling fraud cases with drug companies and making enough money...[ Price : $8.95]
A new GAO report finds that FDA has not considered intentional information security risks or device hacking as a realistic possibi...[ Price : $8.95]
FDA approves Bayer Healthcares Stivarga to treat patients with colorectal cancer that has metastasized after treatment.