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Pfizer and its generic injectables arm, Hospira, received a complete response letter for their proposed biosimilar of epoetin alfa, also known as Epogen and Procrit, following manufacturing issues cited in a February FDA warning. Read More
An FDA advisory committee voted unanimously to recommend to the agency that a diabetic drug is not associated with excessive cardiovascular risk, and also voted 17-to-2 to recommend an added indication that it reduces heart risks in patients with type 2 diabetes. Read More
The FDA needs to receive $1.2 billion between 2018 and 2022 to make possible the changes presented in the user fee reauthorization bill currently before Congress. Read More