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Drugmakers making changes to analytical methods over the lifecycle of a drug should retain samples to permit comparative studies of the new and old methods, the FDA says. Read More
Drugmakers in the EU have less than seven months to conduct risk assessments of all the excipients they use under good manufacturing practices guidelines imposed by the European Commission. Read More
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