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.
An FDA advisory committee voted unanimously on Thursday to recommend approval of Amarin Pharmaceuticals’ Vascepa (icosapent ethyl) to reduce the risk of cardiovascular events in adults. Read More
An HHS proposed rule currently under review at the Office of Management and Budget would have the U.S. pay less than other developed countries for some Medicare drugs by using a “most favored nation” approach, HHS Secretary Alex Azar said Wednesday. Read More
CDER Director Janet Woodcock called for an overhaul of American drug manufacturing to offset the nation’s dependence on APIs made in China, India and elsewhere, in Oct. 30 remarks to a House subcommittee. Read More
The FDA invited comments on a draft guidance that outlines the agency’s best practices for postmarket safety surveillance for drugs and biologics, including product quality issues (PQIs). Read More
The FDA is recommending a second low-temperature test for determining if ranitidine products contain the probable carcinogen N-nitrosodimethylamine (NDMA). Read More
The physician previously pled guilty to 14 counts of illegal distribution of controlled substances in a related criminal case and is expected to be sentenced in January 2020.
Read More
The DEA said that 27 percent of sampled tablets it seized nationwide between January and March 2019 contained potentially lethal doses of fentanyl. Read More
The House Energy and Commerce’s health subcommittee unanimously advanced a bipartisan bill on Wednesday aimed at ending the abuse of citizen petitions to stall generic approvals. Read More
Teva Pharmaceuticals has been hit with a patent infringement suit in a Delaware district court by Switzerland-based Ibsa Pharmaceuticals and Altergon over its generic version of Ibsa’s hypothyroidism treatment Tirosint (levothyroxine). Read More