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 is clarifying when drugmakers should seek formal and informal presubmission meetings with the Office of Orphan Products Development, in an effort to save time and resources. Read More
The FDA Tuesday approved Novartis’ heart failure drug Entresto, which had received priority review and fast track designations to expedite therapies for life-threatening conditions and unmet medical needs. Read More
Purdue Pharma has withdrawn its supplemental new drug application for reformulated OxyContin, causing cancelation of an FDA advisory committee meeting to discuss whether postmarket studies of the product’s extended-release tablets show reduced misuse. Read More
Vertex Pharmaceuticals’ Orkambi has been approved as the first drug intended to treat cystic fibrosis in patients who have two copies of a specific mutation, the FDA announced Friday. Read More
Gilead Sciences has submitted an NDA for a once-daily single tablet regimen to treat HIV-1 infection in adult and pediatric patients 12 years and older, using a priority review voucher that it acquired from Knight Pharmaceuticals for $125 million in November 2014. Read More
Galderma has received FDA approval for its injectable gel Restylane Lyft with lidocaine to correct age-related volume loss in the cheek area for people over 21, offering a nonsurgical option to help restore cheek fullness. Read More
Two patient advocacy groups are suing the FDA to force it to release raw clinical trial data on Gilead Sciences’ groundbreaking hepatitis C drugs Sovaldi and Harvoni. Read More