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GSK urged the agency to “either refrain from taking action to alter Zofran’s pregnancy-related labeling or take action to alter the labeling” and explain which data warranted the labeling changes. Read More
The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended five new drugs and two generics for EU approval at its November meeting and called for restrictions on two others. Read More
In a win for Mallinckrodt, the Patent Trial and Appeal Board (PTAB) invalidated BioVie’s patent on a treatment for ascites — an accumulation of abdominal fluid often linked to advanced liver cirrhosis. Read More
President Trump announced his intention to nominate Hahn as the agency’s leadership role on Nov. 1, and the nomination was officially sent to the Senate. Read More
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