The Trump administration Monday attributed a jump in Medicare Part B premiums and deductibles to increasing spending on physician-administered drugs. The administration is likely to use the increases to justify its proposal for an international...

Enacting drug pricing legislation by the end of December based on the Prescription Drug Pricing Reduction Act (PDPRA) is a top Trump administration priority, Joe Grogan, director of the White House Domestic Policy Council, said...

Gilead plans to ask a federal court to pause a patent infringement lawsuit the federal government filed against the company’s Truvada and Descovy HIV pre-exposure prophylaxis (PrEP) drugs pending resolution of Gilead’s patent challenges by...

FDA announced the establishment of three new offices as part of a wide-ranging reorganization of the Center for Drug Evaluation and Review’s Office of New Drugs. The new organization is flatter and includes new disease-focused...

Sen. Lamar Alexander (R-Tenn.), chairman of the Senate Health, Education, Labor and Pensions Committee, expressed support Wednesday for Stephen Hahn to be confirmed as FDA commissioner. The HELP Committee will hold a hearing on Nov....

Brett Giroir will continue to serve as HHS's assistant secretary for health while heading FDA, according to sources at HHS. Giroir will split his time between FDA’s White Oak campus in Silver Spring, Md., and...

The Trump administration has launched a game of musical chairs that is intended to clear a path for Stephen Hahn to be confirmed as FDA commissioner. When the music stops, it is possible that Hahn...

A survey of Chinese investors revealed broad concern about U.S. restrictions on foreign investment in the life sciences that is diverting Chinese investments to other countries, with Europe cited as the top alternative for investment....

Project Facilitate, an FDA call center that guides physicians through the process of obtaining expanded access -- or compassionate use -- to investigational cancer therapies, handled about 161 requests from its launch on June 3...

CMS has proposed that next-generation sequencing should be covered for Medicare beneficiaries with advanced cancer. In a proposed decision memo , the agency said NGS as a diagnostic laboratory test when performed in a CLIA-certified...

Ken Cuccinelli, acting director of U.S. Citizenship and Immigration Services, Wednesday took responsibility for the Trump administration’s August 2019 decision to initiate deportation proceedings against critically ill patients and their families. Cuccinelli testified to the...

A congressional hearing Wednesday on safeguarding pharmaceutical supply chains will focus on concerns that reliance on Chinese APIs threatens U.S. national security and creates health risks for American patients. The House Energy and Commerce Committee’s...

Participants at a Berkeley conference Tuesday outlined both encouraging and concerning signals for transnational IP litigation in the U.S. and China. While available data suggest domestic and foreign parties have received equitable treatment in each...

Following calls from the White House to end the U.S. HIV epidemic, NIH and the Bill and Melinda Gates Foundation announced a collaboration to invest at least $200 million in the development of low-cost in...

The Advanced Medical Technology Association's new Center for Digital Health will initially advocate for issues relating to cybersecurity, artificial intelligence and information policy. The center, which launched last week, has 47 members who are also...