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.
FEATURED STORIES
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.
Subscribe to BioPharm Executive
Market insights and trending stories for biopharma leaders, in your inbox every Wednesday
THE LATEST
Steve Hoerter, president and chief executive officer of Deciphera, said the acceptance of the NDA brings the company one step closer to its goal of providing a new treatment option for patients with advanced GIST.
A number of new medications stand a shot at early regulatory approval thanks to the U.S. Food and Drug Administration’s priority review program.
In November 2019, the U.S. Food and Drug Administration (FDA) released new draft guidance that would help generic drug companies bring biosimilars to insulin to the market more quickly. And now there are reports that two of the three primary biopharma companies that sell insulin in the U.S. are trying to change that draft guidance.
While fears of a potential coronavirus or flu pandemic continue to grow across the globe, the White House is calling for a 16% cut to the budget of the U.S. Centers for Disease Control, as well as a 10% cut to the Department of Health and Human Services.
Bayer is moving closer to a $10 billion settlement over the Roundup lawsuits and the company is in the midst of restructuring.
Things are looking a little bit rosier for Elizabeth Holmes and the criminal charges against her after a federal judge dismissed some of the charges she is facing.
RRP is a rare, potentially fatal orphan disease caused by the Human Papillomavirus (HPV), a common virus present in 80 percent of people worldwide
A single AQP5+ human gastric stem cell gives rise to a 3D gastric organoid that re-expresses AQP5.
In an analysis of the proposal, Regulatory Focus, the publication of the Regulatory Affairs Professional Society, noted that the FDA, under the proposal, could see $6.2 billion in overall funding.
The FDA gave tentative approval for the drug in 2018, but the holdup was over patent issues.