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A federal judge has ruled that the FDA was right in approving generic versions of Otsuka’s blockbuster antipsychotic Abilify, despite exclusivity remaining on at least one indication, removing any final obstacles to market entry of those drugs Read More
An FDA advisory committee Tuesday voted 12 to 1 to recommend approval of the Vertex Pharmaceuticals Orkambi combination therapy for patients 12 years and older with two copies of the most common cystic fibrosis mutation. Read More
Sponsors seeking approval of new drugs based on published literature or postmarketing data must prove that their drug is comparable to its reference product. Read More
The World Health Organization has added new treatments for hepatitis C to its essential medicines list, including Gilead Sciences’ Sovaldi and Harvoni, but says prices must come down before most people will be able to access them. Read More
The European Medicines Agency has granted orphan medicines designation to Hemispherx Biopharma Europe’s experimental Ebola treatment Ampligen. Read More
Vertex Pharmaceuticals’ Kalydeco/lumacaftor combination therapy may be in danger as regulators question whether it will provide significant improvements in lung function for most cystic fibrosis patients. Read More
Drugmakers can reduce the time it takes to obtain marketing authorization from EU regulators by about two months if they seek scientific advice and make suggested changes to their clinical development plans, a new analysis shows. Read More
Novartis’ Zykadia will soon be available as a second-line treatment for European patients with a specific type of non-small cell lung cancer, following European Medicines Agency approval late last week. Read More
The FDA Friday approved Bayer HealthCare’s Avelox for the treatment of pneumonic and septicemetic plague, under the animal efficacy rule. It also is approved to prevent plague in adults. Read More