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 has notified Biogen Idec that it needs more time to review its BLA for Alprolix after the drugmaker submitted additional data supporting the validation of a key manufacturing step. Read More
The FDA has agreed to review Purdue Pharma's NDA for its investigational Targiniq ER controlled-release tablets CII for the management of chronic pain. Read More
Despite not agreeing on primary endpoints with the FDA before beginning clinical trials for a new sleep disorder drug, Vanda was able to get an almost unanimous recommendation from an advisory committee earlier this month. Read More
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