New York State Attorney General's Office subpoenas "documents related to Amgen's promotional activities, sales and marketing activities, medical education, clinical studies, pricing and contracting, license and distribution agreements and corporate communications," company discloses in a May 22 SEC filing. It is unclear whether the documents are related to a specific product, although the likely suspects are erythropoiesis-stimulating agentsAranesp (darbepoetin alfa) and Epogen (epoetin alfa). The firm also recently has come under scrutiny from Sen. Charles Grassley, R-Iowa, who is looking into Amgen's marketing practices for its EPO products, and how well it is providing drug safety information to FDA...

Two top officials in the US FDA’s device center are warning of delays in the agency’s review of submissions for new products that aren’t directly tied to the coronavirus pandemic.

With 12 new BTDs announced so far this year, 2021 is on pace to match the COVID-19-depressed total number of designations in 2020. Here’s a breakdown of the candidates that have received the designation.