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The FDA wants everyone to know that it doesn’t have a drone program in place, nor is it exploring the technology for inspections or surveillance. Read More
A European Medicines Agency advisory panel has recommended approval of Orexigen’s weight-loss drug Mysimba, alongside diet and exercise in overweight or obese adults. Read More
Phase II trials of a much-lauded Ebola vaccine have been pushed back until at least the second week of February, after African regulators asked GlaxoSmithKline for more information about the upcoming studies. Read More
Drugmakers can now receive a priority review voucher for a separate product, and redeem it within three months, if they pursue development of Ebola treatments. Read More
New Zealand’s regulatory authority is updating its uniform recall procedure for drugs, following a recent decision not to pursue a joint regulatory agency with Australia. Read More
AstraZeneca’s first-in-class ovarian cancer drug Lynparza will soon be available in Europe, following European Medicines Agency approval late this week. Read More
The FDA has cleared Alcon Research’s eardrop Xtoro for acute otitis externa infection, marking the agency’s first new approval of a flouroquinolone antibiotic. Read More
Veloxis Pharmaceuticals has filed a lawsuit demanding the FDA grant final approval of its extended-release immunosuppression drug Envarsus, which is being held up by the exclusivity of a rival product. Read More
The FDA is considering employing unmanned aerial drones to aid in facility inspections, although it’s unclear whether that would encompass drug manufacturing plants. Read More
The FDA’s proposal to survey pharmacists and patients on how changes to the physical appearance of a therapy may affect patient perceptions and drug adherence is raising concerns among both brand and generic drug manufacturers. Read More