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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Clinicians and scientists from National Heart Centre Singapore, Duke-NUS Medical School’s Cardiovascular & Metabolic Disorders Programme (CVMD) and SingHealth Duke-NUS Academic Medical Centre (AMC)s’ discovery of a key driver of fibrosis and inflammation in human diseases is now moving rapidly toward the clinic.
A recent study questions if the FDA and other regulatory agencies worldwide rush certain approvals, particularly at the end of the year in a kind of “desk-clearing” activity.
The site location is in Swiftwater, Pennsylvania.
Merck’s checkpoint inhibitor Keytruda (pembrolizumab) continues moving toward the projections of becoming the world’s best-selling drug.
Polyganics announced that it has obtained CE marking for LIQOSEAL®, its easy-to-use and innovative dural sealant patch, and will launch the device in Europe with immediate effect.
Study showed that two metabolic enzymes in the proline metabolic pathway are potential targets to inhibit cancer cell growth, and offers new hope for effective liver cancer treatments
A Chinese scientist living abroad who has been accused of accepting stolen intellectual property to benefit a pharma startup in China has been extradited to the United States.
This is a list of new molecular entities and new therapeutic biological products approved by the agency’s Center for Biologics Evaluation and Research in 2019.
Three months after it won approval in type 2 diabetes, AstraZeneca’s Farxiga is eying potential regulatory win as a treatment in heart failure patients.
“We are pleased that the FDA recognized Molgradex as a breakthrough therapy for the treatment of aPAP, a debilitating rare lung disease with no approved pharmacologic treatment options,” said Rob Neville, Savara’s chief executive officer.