We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA also should deny any applications from bortezomib products with multiple myeloma indications if their labeling does not address key safety issues, Millennium says. Read More
Takeda subsidiary Millennium Pharmaceuticals called on the FDA to withhold approval for generic versions of its drug Velcade (bortezomib) until at least next February, when a relevant exclusivity period expires. Read More
The FDA surpassed many of its performance goals for generic drug applications through 2016, but the agency needs a plan for the user fees collected but not spent in the same year, according to the GAO. Read More
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