Policy
The U.S. regulator shared the roadmap for implementing the program, first proposed in August 2025, and teased changes made in response to industry feedback.
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Former European Trade Commissioner Phil Hogan and former US Senator Richard Burr, speaking on a panel at the J.P. Morgan Healthcare Conference, pushed to see a larger picture beyond the Trump administration’s year of chaos and confusion.
Only a handful of the top pharmas have signed Most Favored Nation drug pricing deals with the White House, while smaller biotechs continue to hang in limbo.
Policy initiatives have come fast and furious at the FDA this year. While guidances on rare diseases and vaccines have consumed most of the ink, policy shifts aimed at improving FDA efficiencies and reshoring U.S. manufacturing also got some attention. Here, BioSpace rounds up more than a dozen initiatives relevant to the biopharma industry.
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The plan, put forth by House Speaker Nancy Pelosi, was passed last week on a mostly party-line vote, with support from two Republicans.
BMS accused Kite and Gilead of copying the research conducted at Memorial Sloan Kettering to push the development of Yescarta.
The FDA approved extended-release 11 mg and 22 mg tablets as a once-daily treatment from the chronic inflammatory condition.
The U.S. Food and Drug Administration is wrapping up 2019 with a few PDUFA dates. Here’s a look.
The U.S. Senate confirmed Hahn as the new commissioner Thursday in a 72-18 vote.
House Speaker Nancy Pelosi’s drug pricing reform bill passed the House of Representatives in a mostly party-line vote and will now head to the U.S. Senate, where its chances of moving forward in the Republican-led chamber are slim.
The agency is requiring Sarepta to conduct a confirmatory trial, which Sarepta says will conclude by 2024.
SureClinical, a global provider of innovative cloud solutions for the health sciences market announced its new cloud-based regulatory document management solution for clinical investigator sites, SureISF.
MagForce successfully hosted the second session of its practice-oriented, unique, multifaceted application training for the use of the NanoTherm therapy system in treating brain tumors
The FDA advisory committee met and voted 11 to 2 against recommending approval of Brinavess, citing safety concerns. The FDA is not required to follow the recommendations of its adcoms, but typically does.