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
The company disclosed late Monday that the U.S. Food and Drug Administration placed a clinical hold on its proposed gene therapy treatment for methylmalonic academia.
Linshom announced U.S. Food and Drug Administration 510 clearance of the company’s first product, a small, non-invasive respiratory monitor that addresses the growing need for continuous respiratory monitoring for patients susceptible to respiratory depression and compromise.
“The FDA filing acceptance for Libervant is an important milestone in our mission to provide epilepsy patients with a broader array of treatment options, that represent major contributions to patient care,” said Keith J. Kendall, Aquestive’s chief executive officer.
Myovant to Seek Regulatory Approval of Uterine Fibroid Treatment Following Positive Late-Stage Trial
More than five million women suffer from symptoms of uterine fibroids, with more than half of them estimated to have received inadequate treatment. However, new data released by Myovant shows that concerns of inadequate treatment could soon change.
A four-year-old legal battle between Agilent Technologies and Twist Bioscience came to a conclusion Thursday. Twist agreed to pay Agilent $22.5 million to settle the lawsuit filed in 2016.
Pharma and life science companies from across the globe provide updates on their pipelines and businesses.
The Wuhan Institute of Virology, part of the China Academy of Sciences, has applied to patent the use of Gilead Sciences’ remdesivir to treat the current coronavirus outbreak.
Chants of “H.R. 3” broke out in the House of Representatives chamber during Tuesday night’s State of the Union Address as Democratic lawmakers urged action on the bill passed late last year that could impact the price of prescription medications paid for by government-funded health programs.
Unique feature of bioSens-All™ technology enables discovery of therapeutics for pathologies linked to GPCR mistrafficking
The National Institutes of Health ceased administration of an investigational HIV vaccine after interim data revealed that the treatment was not working in preventing the virus.