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The FDA has accepted Amicus Therapeutics’ submission of its rare disease drug for review, a reversal from its decision under the Obama administration. Read More
An FDA advisory committee voted to recommend that Wyeth’s Mylotarg return to the U.S. market as a treatment for CD33-positive acute myeloid leukemia in combination with daunorubicin and cytarabine. 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 approved the most generic drugs during May and June that is has since it began tallying approvals, according to the agency’s latest report on the generics program — helping Commissioner Scott Gottlieb make good on his early-tenure promises to speed generics to market in an effort to lower U.S. drug prices. Read More
Though glutamine is currently sold as a nutritional supplement and a medical food, Emmaus’ L-glutamine will be produced and sold as a prescription drug. 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
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