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Allergan and partner Gedeon Richter received FDA approval Thursday for antipsychotic Vraylar to treat schizophrenia and manic or mixed episodes associated with bipolar I disorder in adults. Read More
The FDA granted fast track designation to a drug from Mapp Biopharmaceutical to treat the Ebola virus and to Dimension Therapeutics to treat patients with hemophilia B. Read More
HHS will collaborate with biopharmaceutical giant AstraZeneca on an antibiotic initiative as part of a biodefense preparedness plan for dealing with public health threats. Read More
Addyi, the pill for premenopausal women with hypoactive sexual desire disorder, received FDA approval last month despite dissent from some reviewers that marginal clinical benefits did not outweigh the risks, an FDA summary said. Read More
CDER Director Janet Woodcock came under fire Thursday from senators demanding to know why the FDA is years behind Europe and Canada in establishing a workable program for biosimilars. Read More