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.
Congressional negotiators are working to hammer out a new federal budget proposal for fiscal 2014 and fiscal 2015, and a group of lawmakers hope to use the budget deal to shield FDA user fee revenue from any across-the-board sequestration cuts. Read More
The FDA has handed Forest Laboratories and Gedeon Richter a complete response letter asking for more data on cariprazine, the companies’ drug candidate to treat schizophrenia and manic or mixed episodes of bipolar I disorder in adults. Read More
Regulators in the U.S. and EU have paved the way for a new treatment approach to treat chronic hepatitis C, clearing highly anticipated new drugs from Gilead Sciences and Janssen/Medivir. Read More
Amgen’s first long-term trial for its next-generation heart drug evolocumab has shown positive results, heating up the race to develop the emerging class of drugs known as PCSK9 inhibitors. Read More
The EMA has put Boehringer Ingelheim's hepatitis C drug candidate faldaprevir on a speedy review pathway based on studies involving 3,300 patients. Read More
The FDA has extended its review of Mallinckrodt’s NDA for its investigational painkiller Xartemis XR by 90 days, saying it needs more time to review the drug’s proposed labeling. Read More
The FDA’s Office of New Drugs has notified Amarin that it is refusing to review the company’s appeal of the agency’s decision to rescind the SPA for the drugmaker’s ANCHOR study of its heart drug Vascepa. Read More
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee strongly urged approval of BioMarin’s orphan drug Vimizim to treat the rare disease Mucopolysaccharidosis Type IVA, overriding agency concerns of limited supportive data. Read More
Sanofi has decided to stop pursuing regulatory filing for its blood cancer drug fedratinib after new safety concerns arose from several clinical trials. Read More