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In anticipation of proposed guidance on biosimilar interchangeability, AbbVie is requesting that the FDA hold a hearing to ensure the agency considers all viewpoints. Read More
Nearly a dozen organizations are calling for clarification on a draft FDA plan to label injectable therapies that are meant to be used multiple times by a single patient as products for “single patient–use.” Read More
While Teva Pharmaceutical and Takeda Pharmaceutical have framed a previously disclosed joint venture in Japan as a “partnership,” new details about the arrangement show that Takeda is selling off drugs for stock. Read More