We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA late Wednesday approved two breakthrough therapies for idiopathic pulmonary fibrosis: Boehringer Ingelheim’s Ofev and Intermune’s Esbriet, both of which are set to hit the market within the next two weeks, the companies said. Read More
The UK’s health cost watchdog says it is not ready to change the way it appraises medicines and other technologies, but acknowledges that further consideration is needed of how new treatments are developed, evaluated and supported for coverage. Read More
A question-and-answer document released by the European Medicines Agency in September clarifies terms of engagement and expected outcomes for applicants to the agency’s adaptive licensing pilot program. Read More
Takeda has asked a federal court to rescind the FDA’s approval last month of Hikma Pharmaceutical’s gout treatment Mitigare, claiming that the agency improperly cleared the rival company’s drug application without referencing Takeda’s own gout therapy Colcrys or its safety warnings. Read More
The FDA approved Eisai’s Akynzeo to treat nausea and vomiting from chemotherapy, the latest success by the Japanese drugmaker to expand its portfolio of such products. Read More
Millennium Pharmaceutical’s received another victory in its efforts to bolster the use of its blockbuster oncology drug Velcade, receiving FDA approval for a new indication for previously untreated patients with mantle cell lymphoma. Read More
Regeneron Pharmaceuticals’ eye injection Eylea received an expanded indication from the FDA to cover macular edema following branch retinal vein occlusion. Read More